Kaye/Bassman International
Sr. Product Development Engineer
Kaye/Bassman International, Woburn, Massachusetts, us, 01813
Overview
A well-funded, innovation-driven biotechnology company in the Greater Boston area is developing a new drug delivery device designed to make treatments more effective, stable, and accessible worldwide. The technology enables sustained delivery through the skin in minutes — redefining how therapeutics are administered. We’re seeking a
Senior/Principal Engineer, Product Development
to lead the design and advancement of a
reusable applicator system
supporting this next-generation delivery platform. The ideal candidate is a hands-on engineer with deep experience in medical device design, development, and scale-up under design control. Key Responsibilities
Lead product design and development for a
reusable drug-device delivery system , from concept through verification and validation. Drive
design for manufacturability
and collaborate with external design and manufacturing partners to support pre-clinical and clinical builds. Partner cross-functionally with R&D, Quality, Regulatory, and Human Factors teams to align technical solutions with clinical and user needs. Generate and maintain documentation to support
Design Control (21 CFR 820 / ISO 13485)
and
Risk Management (ISO 14971)
requirements. Develop and execute test methods, protocols, and reports; perform design verification and validation activities. Conduct
FMEAs , material selection, tolerance analysis, and prototype evaluations to inform robust design decisions. Mentor junior engineers and contribute to a collaborative, fast-paced development environment. Qualifications
BS or MS in Mechanical, Biomedical, or related Engineering discipline. 7+ years
of direct medical device development experience, ideally within a
combination-product environment . Proven expertise in
hands-on product design , prototyping, and testing for regulated devices. Strong understanding of
Design Controls, Risk Management, and DFM principles . Experience with
DOE/SPC, IQ/OQ/PQ , and process validation a plus. Demonstrated ability to work effectively across multidisciplinary teams and external vendors. Self-starter with an entrepreneurial mindset and passion for bringing transformative healthcare technologies to market. Why Join
This is a rare opportunity to join a growing, well-funded team that’s
changing the future of drug delivery . You’ll have direct impact on design decisions, visibility with leadership, and the ability to see your work advance from concept to clinic. Seniority level
Mid-Senior level Employment type
Full-time Job function / Industries
Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
#J-18808-Ljbffr
A well-funded, innovation-driven biotechnology company in the Greater Boston area is developing a new drug delivery device designed to make treatments more effective, stable, and accessible worldwide. The technology enables sustained delivery through the skin in minutes — redefining how therapeutics are administered. We’re seeking a
Senior/Principal Engineer, Product Development
to lead the design and advancement of a
reusable applicator system
supporting this next-generation delivery platform. The ideal candidate is a hands-on engineer with deep experience in medical device design, development, and scale-up under design control. Key Responsibilities
Lead product design and development for a
reusable drug-device delivery system , from concept through verification and validation. Drive
design for manufacturability
and collaborate with external design and manufacturing partners to support pre-clinical and clinical builds. Partner cross-functionally with R&D, Quality, Regulatory, and Human Factors teams to align technical solutions with clinical and user needs. Generate and maintain documentation to support
Design Control (21 CFR 820 / ISO 13485)
and
Risk Management (ISO 14971)
requirements. Develop and execute test methods, protocols, and reports; perform design verification and validation activities. Conduct
FMEAs , material selection, tolerance analysis, and prototype evaluations to inform robust design decisions. Mentor junior engineers and contribute to a collaborative, fast-paced development environment. Qualifications
BS or MS in Mechanical, Biomedical, or related Engineering discipline. 7+ years
of direct medical device development experience, ideally within a
combination-product environment . Proven expertise in
hands-on product design , prototyping, and testing for regulated devices. Strong understanding of
Design Controls, Risk Management, and DFM principles . Experience with
DOE/SPC, IQ/OQ/PQ , and process validation a plus. Demonstrated ability to work effectively across multidisciplinary teams and external vendors. Self-starter with an entrepreneurial mindset and passion for bringing transformative healthcare technologies to market. Why Join
This is a rare opportunity to join a growing, well-funded team that’s
changing the future of drug delivery . You’ll have direct impact on design decisions, visibility with leadership, and the ability to see your work advance from concept to clinic. Seniority level
Mid-Senior level Employment type
Full-time Job function / Industries
Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
#J-18808-Ljbffr