Kymanox
(Contract) Senior/Principal R&D Engineer, Design & Innovation
Kymanox, King of Prussia, Pennsylvania, United States
Overview
(Contract) Senior/Principal R&D Engineer, Design & Innovation. This role is hybrid with a minimum of 3 days in the office. Responsibilities
Provide supervision and leadership of direct reports within the team, if applicable. Interface with clients and project leads on tasks as a technical lead. Design and prototype device systems and subsystems using CAD and prototyping techniques (e.g., 3D printing, machining). Perform analytical assessments to inform design directions; create test plans and determine in-house vs. outsourced execution. Support testing functions and oversee test method development; aggregate, analyze, and report test data to the design team. Identify and mitigate risks related to device functionality, reliability, safety, COGs, and manufacturing scalability. Collaborate with cross-functional teams and work within final assembly manufacturing environments; assist in early-stage process development and manufacturing optimization to meet design intent. Work with and manage external suppliers, conduct DFM reviews, and go on-site as needed. Conduct technology tear-down studies; design and set up feasibility tests; develop failure analysis models using simulation tools. Participate in strategic planning activities and mentor other engineering team members. Educational Background
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related science field. Experience
10-15 years of experience in a product development environment, preferably with class II or III medical devices. Experience in design for high-volume manufacture; strong leadership and project management within testing and validation. Experience in New Product Development and knowledge of design controls. Experience in disposable, bio-compatible fluid paths and/or container solutions is a plus; track record of generating novel ideas or IP is a plus. Proficiency with MS Office; statistical software (e.g., Minitab); SolidWorks for 3D modeling; ability to develop/review 2D drawings for fixtures/components. Proficiency with Matlab or Python is a strong plus; experience with universal testing machines and customizing test procedures. Familiarity with ISO 11608 and ISO 11040 core standards for drug-delivery devices; experience with metrology and managing external vendors for metrology/testing is a plus. Desired Aptitude And Skill Set
Act as technical lead on multiple projects; author technical reports and presentations. Design and prototype device systems using CAD and prototyping techniques; perform analytical assessments to inform design decisions. Develop and manage test plans; analyze test data and provide feedback to the design team; mitigate risks related to device functionality, safety, and manufacturing scalability. Collaborate in a matrixed team environment; communicate project progress and technical results to clients; follow SOPs and complete training requirements. Support early-stage process development and manufacturing optimization; contribute to internal and client projects. Travel
Up to 20% travel possible. Compensation
Pay rate commensurate with experience, qualifications, and market conditions. About Kymanox
Kymanox is a life sciences professional services company delivering projects across 20+ countries. We support life science products from biotech to medical devices and combination products, with offices in multiple locations. Equal opportunity employer; we comply with local, state, and federal laws and HR best practices.
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(Contract) Senior/Principal R&D Engineer, Design & Innovation. This role is hybrid with a minimum of 3 days in the office. Responsibilities
Provide supervision and leadership of direct reports within the team, if applicable. Interface with clients and project leads on tasks as a technical lead. Design and prototype device systems and subsystems using CAD and prototyping techniques (e.g., 3D printing, machining). Perform analytical assessments to inform design directions; create test plans and determine in-house vs. outsourced execution. Support testing functions and oversee test method development; aggregate, analyze, and report test data to the design team. Identify and mitigate risks related to device functionality, reliability, safety, COGs, and manufacturing scalability. Collaborate with cross-functional teams and work within final assembly manufacturing environments; assist in early-stage process development and manufacturing optimization to meet design intent. Work with and manage external suppliers, conduct DFM reviews, and go on-site as needed. Conduct technology tear-down studies; design and set up feasibility tests; develop failure analysis models using simulation tools. Participate in strategic planning activities and mentor other engineering team members. Educational Background
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related science field. Experience
10-15 years of experience in a product development environment, preferably with class II or III medical devices. Experience in design for high-volume manufacture; strong leadership and project management within testing and validation. Experience in New Product Development and knowledge of design controls. Experience in disposable, bio-compatible fluid paths and/or container solutions is a plus; track record of generating novel ideas or IP is a plus. Proficiency with MS Office; statistical software (e.g., Minitab); SolidWorks for 3D modeling; ability to develop/review 2D drawings for fixtures/components. Proficiency with Matlab or Python is a strong plus; experience with universal testing machines and customizing test procedures. Familiarity with ISO 11608 and ISO 11040 core standards for drug-delivery devices; experience with metrology and managing external vendors for metrology/testing is a plus. Desired Aptitude And Skill Set
Act as technical lead on multiple projects; author technical reports and presentations. Design and prototype device systems using CAD and prototyping techniques; perform analytical assessments to inform design decisions. Develop and manage test plans; analyze test data and provide feedback to the design team; mitigate risks related to device functionality, safety, and manufacturing scalability. Collaborate in a matrixed team environment; communicate project progress and technical results to clients; follow SOPs and complete training requirements. Support early-stage process development and manufacturing optimization; contribute to internal and client projects. Travel
Up to 20% travel possible. Compensation
Pay rate commensurate with experience, qualifications, and market conditions. About Kymanox
Kymanox is a life sciences professional services company delivering projects across 20+ countries. We support life science products from biotech to medical devices and combination products, with offices in multiple locations. Equal opportunity employer; we comply with local, state, and federal laws and HR best practices.
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