Job Title: Principal Mechanical Engineer Location: Raleigh, NC Duration: 3 months Job Summary The Principal Mechanical Engineer will develop new products, redesign existing products, and perform research and testing on product concepts for medical devices. This individual will support research, development, and commercialization of medical devices aligned with business objectives. The role spans concept development, design, verification testing, and transfer to manufacturing. Candidates must have medical device industry experience and be familiar with regulatory and quality requirements throughout the product development lifecycle. Responsibilities: Technical Lead Provide technical leadership on system features and functions for medical devices. Collaborate with and lead cross-functional engineering teams. Mechanical Engineering Lead development projects and manage assigned team members to ensure on-time progress. Conduct engineering analyses, feasibility studies, and support advanced development efforts. Provide broad mechanical engineering expertise across all product lifecycle phases. Innovation Design, develop, and test innovative concepts to support clinical, patient, and business needs. Collaborate with engineering and marketing teams on product feasibility evaluations. Serve as a subject matter expert for designing and building test setups and fixtures. Documentation Maintain accurate documentation in accordance with GDP and GMP. Write product requirements and specifications. Plan, design, execute, and report system experiments for feature development and roadmap activities. Test Methods Develop test plans, validate designs, run performance calculations, and approve prototypes. Validate test tools and setups as needed. Prototype Manufacturing Lead prototype builds, create BOMs, order materials, and train lab technicians. Work with manufacturing and operations teams to develop device build processes. Operate key lab equipment (oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulse-echo fixture, cryostats). Conduct PCBA testing and soldering. Maintain strong laboratory practice standards. Essential SkillsLead Self Time Management Digital Acumen Problem Solving Emotional Intelligence Resiliency Communication Lead Others Leadership Collaboration Project Management Motivation & Influence Technical & Functional Skills Deep knowledge of test method validation, GR&R, GD&T, and statistical analysis SolidWorks or similar CAD expertise Understanding of ISO Quality Systems and FDA medical device regulations Familiarity with mechanical and electromechanical manufacturing processes Minimum Qualifications Bachelor's degree in Mechanical, Industrial, Electrical, or related engineering field 10+ years of mechanical design/manufacturing experience in medical devices or related fields Experience with Design Controls and process verification/validation Experience with manufacturing and assembly process validation (IQ, OQ, PQ) Knowledge of injection molding, die casting, metal stamping, machining processes Experience with fixtures, gauges, and tooling design Preferred Qualifications Six Sigma or SPC knowledge; Green or Black Belt preferred Experience with project management tools and methodologies Travel Requirements Up to 20% Physical Requirements Ability to sit, stand, lift up to 25 lbs, and perform general office and lab tasks Frequent bending, stooping, and reaching
12/05/2025
Full time
Job Title: Principal Mechanical Engineer Location: Raleigh, NC Duration: 3 months Job Summary The Principal Mechanical Engineer will develop new products, redesign existing products, and perform research and testing on product concepts for medical devices. This individual will support research, development, and commercialization of medical devices aligned with business objectives. The role spans concept development, design, verification testing, and transfer to manufacturing. Candidates must have medical device industry experience and be familiar with regulatory and quality requirements throughout the product development lifecycle. Responsibilities: Technical Lead Provide technical leadership on system features and functions for medical devices. Collaborate with and lead cross-functional engineering teams. Mechanical Engineering Lead development projects and manage assigned team members to ensure on-time progress. Conduct engineering analyses, feasibility studies, and support advanced development efforts. Provide broad mechanical engineering expertise across all product lifecycle phases. Innovation Design, develop, and test innovative concepts to support clinical, patient, and business needs. Collaborate with engineering and marketing teams on product feasibility evaluations. Serve as a subject matter expert for designing and building test setups and fixtures. Documentation Maintain accurate documentation in accordance with GDP and GMP. Write product requirements and specifications. Plan, design, execute, and report system experiments for feature development and roadmap activities. Test Methods Develop test plans, validate designs, run performance calculations, and approve prototypes. Validate test tools and setups as needed. Prototype Manufacturing Lead prototype builds, create BOMs, order materials, and train lab technicians. Work with manufacturing and operations teams to develop device build processes. Operate key lab equipment (oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulse-echo fixture, cryostats). Conduct PCBA testing and soldering. Maintain strong laboratory practice standards. Essential SkillsLead Self Time Management Digital Acumen Problem Solving Emotional Intelligence Resiliency Communication Lead Others Leadership Collaboration Project Management Motivation & Influence Technical & Functional Skills Deep knowledge of test method validation, GR&R, GD&T, and statistical analysis SolidWorks or similar CAD expertise Understanding of ISO Quality Systems and FDA medical device regulations Familiarity with mechanical and electromechanical manufacturing processes Minimum Qualifications Bachelor's degree in Mechanical, Industrial, Electrical, or related engineering field 10+ years of mechanical design/manufacturing experience in medical devices or related fields Experience with Design Controls and process verification/validation Experience with manufacturing and assembly process validation (IQ, OQ, PQ) Knowledge of injection molding, die casting, metal stamping, machining processes Experience with fixtures, gauges, and tooling design Preferred Qualifications Six Sigma or SPC knowledge; Green or Black Belt preferred Experience with project management tools and methodologies Travel Requirements Up to 20% Physical Requirements Ability to sit, stand, lift up to 25 lbs, and perform general office and lab tasks Frequent bending, stooping, and reaching
Job Title: Process Laboratory Technician Location: Princeton, NJ Type: Contract Compensation: $21/hr Contractor Work Model: Onsite Mon-Fri, 8:30AM-4:30PM Must Haves/Requirements: High school diploma or equivalent with over 5 years of relevant experience. Ability to use mathematics and technical skills on assigned tasks with minimal supervision. Ability to develop, organize and prioritize tasks within assigned projects and work. Good written and verbal communication skills. Computer proficiency in MS Office (Word, Excel, PowerPoint). Some Quality Assurance (QA) experience is preferred. Some experience with analytical instrumentation and ability to troubleshoot issues. Good Mechanical Aptitude. Displays Leadership Skills. Knowledge of Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Responsibilities: Assists Engineer(s) in various Pilot Plant activities. Performs pilot plant assignments in order to meet pilot plant development requirements. Assists in batch preparation including but not limited to conducting pre-weighs, preparing starch trays, making vitamin blends, preparing the bulk batch, and depositing. Assists with set-up and clean-up for pilot plant batches. Performs preventative maintenance on pilot plant instruments and troubleshoots instrument issues as needed. Records data during batches and interprets results. Conducts analytical measurements to include but not limited to moisture analysis, viscosity, Brix, specific gravity and pH. Assists with setting up pilot plant instruments in preparation for batching. Cleans instruments and pilot plant after each batch. Conducts housekeeping of pilot plant workspace and maintenance of instruments. Monitors pilot plant trials as assigned by supervisor(s) including assisting in troubleshooting batches. Performs any other related duties requested by supervisor(s) with a minimum of instruction. Has experience operating in a Good Manufacturing Practices (GMP) environment with minimal guidance. Must be able to follow established pilot plant, Quality and Safety SOPs.
12/04/2025
Full time
Job Title: Process Laboratory Technician Location: Princeton, NJ Type: Contract Compensation: $21/hr Contractor Work Model: Onsite Mon-Fri, 8:30AM-4:30PM Must Haves/Requirements: High school diploma or equivalent with over 5 years of relevant experience. Ability to use mathematics and technical skills on assigned tasks with minimal supervision. Ability to develop, organize and prioritize tasks within assigned projects and work. Good written and verbal communication skills. Computer proficiency in MS Office (Word, Excel, PowerPoint). Some Quality Assurance (QA) experience is preferred. Some experience with analytical instrumentation and ability to troubleshoot issues. Good Mechanical Aptitude. Displays Leadership Skills. Knowledge of Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Responsibilities: Assists Engineer(s) in various Pilot Plant activities. Performs pilot plant assignments in order to meet pilot plant development requirements. Assists in batch preparation including but not limited to conducting pre-weighs, preparing starch trays, making vitamin blends, preparing the bulk batch, and depositing. Assists with set-up and clean-up for pilot plant batches. Performs preventative maintenance on pilot plant instruments and troubleshoots instrument issues as needed. Records data during batches and interprets results. Conducts analytical measurements to include but not limited to moisture analysis, viscosity, Brix, specific gravity and pH. Assists with setting up pilot plant instruments in preparation for batching. Cleans instruments and pilot plant after each batch. Conducts housekeeping of pilot plant workspace and maintenance of instruments. Monitors pilot plant trials as assigned by supervisor(s) including assisting in troubleshooting batches. Performs any other related duties requested by supervisor(s) with a minimum of instruction. Has experience operating in a Good Manufacturing Practices (GMP) environment with minimal guidance. Must be able to follow established pilot plant, Quality and Safety SOPs.
Title: Quality Laboratory Technician Location: Bethlehem, PA Type: Contract to Hire Start: Immediate Overview: This position is responsible for the day-to-day activities involved in QC analytical testing within a quality control microbiological laboratory environment. This position is also responsible for keeping the QC Laboratory Supervisor informed of any quality control laboratory issues that could result in off-specification product. Responsibilities: Perform microbial assays and experiments related to eGMP procedures, as well as quality control and quality assurance of raw materials, in-process products, finished products, and stability studies to determine conformance to accepted specifications for a particular chemical or physical property. Investigate the growth, structure, development, and other characteristics of microscopic organisms such as bacteria, algae, and fungi. Monitor and assess samples from a range of sources. Use a variety of microbial identification methods to test samples. Teach the development and behavior of specific microorganisms in the environment. Develop and plan methods to prevent the spread of contamination via water supply points used for analytical testing, cleaning, and manufacturing. Trace, monitor, and eliminate contamination issues when they arise. Plan, implement, and evaluate new products in clinical trials. Perform literature reviews and develop and validate microbial methods for testing new products. Develop a decontamination plan and an environmental monitoring program to be utilized across all DCI facilities. Grow specific microbe cultures, such as those used for DCI analysis. Manage and oversee microbiological laboratory work. Follow SOPs and record data precisely within notebooks and logbooks for review. Participate in writing and reviewing test method procedures related to quality control laboratories. Perform a variety of tests to aid in the maintenance and certification of test instruments and apparatus to ensure compliance with regulatory requirements. Prepare cell cultures, media, reagents, solutions, instruments, and apparatus according to established procedures to support testing activities within the quality control labs. Requirements: BS degree in Microbiology, Biology, Biochemistry, or Life Sciences Good written and oral communication skills Proficiency with MS Office applications Ability to work with a high degree of accuracy Above-average attention to detail Excellent organizational skills Ability to multitask in a stressful environment Strong analytical skills and experience with implementation and administration of cGMP policies and procedures Excellent problem-solving and interpersonal communication skills Strong technical writing skills for documents and research reports Ref:
12/03/2025
Full time
Title: Quality Laboratory Technician Location: Bethlehem, PA Type: Contract to Hire Start: Immediate Overview: This position is responsible for the day-to-day activities involved in QC analytical testing within a quality control microbiological laboratory environment. This position is also responsible for keeping the QC Laboratory Supervisor informed of any quality control laboratory issues that could result in off-specification product. Responsibilities: Perform microbial assays and experiments related to eGMP procedures, as well as quality control and quality assurance of raw materials, in-process products, finished products, and stability studies to determine conformance to accepted specifications for a particular chemical or physical property. Investigate the growth, structure, development, and other characteristics of microscopic organisms such as bacteria, algae, and fungi. Monitor and assess samples from a range of sources. Use a variety of microbial identification methods to test samples. Teach the development and behavior of specific microorganisms in the environment. Develop and plan methods to prevent the spread of contamination via water supply points used for analytical testing, cleaning, and manufacturing. Trace, monitor, and eliminate contamination issues when they arise. Plan, implement, and evaluate new products in clinical trials. Perform literature reviews and develop and validate microbial methods for testing new products. Develop a decontamination plan and an environmental monitoring program to be utilized across all DCI facilities. Grow specific microbe cultures, such as those used for DCI analysis. Manage and oversee microbiological laboratory work. Follow SOPs and record data precisely within notebooks and logbooks for review. Participate in writing and reviewing test method procedures related to quality control laboratories. Perform a variety of tests to aid in the maintenance and certification of test instruments and apparatus to ensure compliance with regulatory requirements. Prepare cell cultures, media, reagents, solutions, instruments, and apparatus according to established procedures to support testing activities within the quality control labs. Requirements: BS degree in Microbiology, Biology, Biochemistry, or Life Sciences Good written and oral communication skills Proficiency with MS Office applications Ability to work with a high degree of accuracy Above-average attention to detail Excellent organizational skills Ability to multitask in a stressful environment Strong analytical skills and experience with implementation and administration of cGMP policies and procedures Excellent problem-solving and interpersonal communication skills Strong technical writing skills for documents and research reports Ref:
Job Title: Metrology Technician Location: West Point, Pennsylvania Type: Full-time Compensation: $30 - $35 hourly Work Model: Onsite Responsibilities: Provides comprehensive, compliant technical services and support for miscellaneous instrumentation and instrumented systems in laboratory, production, and utility environments. Services include: • Instrumentation calibration and related services • Preventive and restorative maintenance • Equipment validation and qualification • Systems retrofit and upgrade support Experience/Skills Required: • 1-5 years experience related to the maintenance and calibration of measuring instrumentation including temperature, humidity, pressure, time, speed, mass, pH, conductivity, and dimensional. Quality System compliance and pharmaceutical experience is strongly preferred. • Sound knowledge and application of varied instrumentation and related equipment in laboratory, manufacturing, and utility environments. • High level functionality and experience with personal computers and standard office applications. • Working knowledge of FDA, GMP, GLP, and USP compliance standards. • Physical ability to lift 45 pounds to shoulder height. • Valid driver's license and dependable transportation is required. Additional Expectations: • Responsible for compliant cGDP (current Good Documentation Practices), as well as performing all duties and functions in accordance with established ISO quality systems. • Expected to perform all technical services in accordance with established and approved protocols, procedures, and work instructions. • Expected to build a high-level interaction with client site contacts in order to foster trust and confidence in our service team in order to facilitate expanded services and growth. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref: Clinical
12/03/2025
Full time
Job Title: Metrology Technician Location: West Point, Pennsylvania Type: Full-time Compensation: $30 - $35 hourly Work Model: Onsite Responsibilities: Provides comprehensive, compliant technical services and support for miscellaneous instrumentation and instrumented systems in laboratory, production, and utility environments. Services include: • Instrumentation calibration and related services • Preventive and restorative maintenance • Equipment validation and qualification • Systems retrofit and upgrade support Experience/Skills Required: • 1-5 years experience related to the maintenance and calibration of measuring instrumentation including temperature, humidity, pressure, time, speed, mass, pH, conductivity, and dimensional. Quality System compliance and pharmaceutical experience is strongly preferred. • Sound knowledge and application of varied instrumentation and related equipment in laboratory, manufacturing, and utility environments. • High level functionality and experience with personal computers and standard office applications. • Working knowledge of FDA, GMP, GLP, and USP compliance standards. • Physical ability to lift 45 pounds to shoulder height. • Valid driver's license and dependable transportation is required. Additional Expectations: • Responsible for compliant cGDP (current Good Documentation Practices), as well as performing all duties and functions in accordance with established ISO quality systems. • Expected to perform all technical services in accordance with established and approved protocols, procedures, and work instructions. • Expected to build a high-level interaction with client site contacts in order to foster trust and confidence in our service team in order to facilitate expanded services and growth. System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref: Clinical
