Sr. Device Engineer (Medical Devices)

Location: Hybrid, Parsippany, New Jersey, United States. The role is office-based and supports virtual teams across global time zones. Travel of up to 20% may be required. Permanent U.S. work authorization is required; U.S. visa sponsorship is not available.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% performance bonus.

Company

hirify.global develops and manufactures medicines and related medical devices and combination products.

What you will do

• Manage the device lifecycle for on-market medical devices and combination products.
• Lead device and manufacturing process changes, including technical impact assessments, risk-file updates, and design verification planning.
• Develop experimental protocols, conduct experiments, analyze results, and establish test methods.
• Coordinate between Device Engineering Lifecycle Management, production sites, Regulatory, and Quality colleagues.
• Lead design change projects, track progress, communicate status, and execute Design History File updates.
• Support non-conformance, material and process qualification, CAPA, complaint investigations, and design-control documentation.

Requirements

• Bachelor's degree with at least 2 years of experience, master's degree with 0+ years, associate's degree with 6 years, or high school diploma with 8 years of relevant experience.
• Knowledge and experience in device design control, risk management, medical devices, and combination products.
• Experience analyzing patient and user impact.
• Practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and related standards.
• Critical thinking, problem-solving, independent work, teamwork, and statistical data-analysis skills.
• Must be authorized to work permanently in the United States; visa sponsorship is not available.

Nice to have

• Pharmaceutical experience and familiarity with package-performance testing equipment and methods.
• Continuous improvement and Statistical Process Control experience, including DMAIC and Six Sigma.
• Knowledge of regional pharmaceutical compendia testing requirements.
• Leadership, mentoring, communication, organizational, and attention-to-detail skills.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot responsibly for problem solving and productivity.

Culture & Benefits

• Hybrid, office-based work supporting virtual teams through Webex and phone.
• Comprehensive health, prescription drug, dental, and vision coverage.
• 401(k) matching and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Participation in hirify.global's Global Performance Plan with a 10% bonus target.