Associate Principal Engineer (Drug-Device Combination Products)

Location: Rahway, New Jersey, United States; hybrid work arrangement; 10% travel; domestic relocation indicated.

Base salary: $142,400–$224,100 annually, plus potential annual bonus and long-term incentive.

Company

hirify.global develops pharmaceutical products and drug-device combination products through its Device Development & Technology organization.

What you will do

• Lead device development sub-teams, establish technical roadmaps and integrated schedules, and allocate resources across internal specialists and external partners.
• Coordinate device development with clinical supply, formulation, filling operations, regulatory submissions, and program milestones.
• Lead stage-gate reviews, resolve trade-offs involving form, fit, function, manufacturability, cost, and schedule, and oversee design verification and manufacturing readiness.
• Own design history files, design control strategy, risk analyses, technical specifications, and verification and validation programs.
• Direct device OEMs, tooling and molding vendors, primary container suppliers, and CDMOs while assessing manufacturing processes and control strategies.
• Author and defend device sections of regulatory filings, respond to health authority requests, support inspections and audits, and mentor early-to-mid-career engineers.

Requirements

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline with 8+ years of progressive regulated-industry experience in medical device or combination product development; or an MS with 6+ years of relevant experience; or a PhD with 4+ years of relevant experience.
• Proven experience leading cross-functional engineering teams or sub-teams in a matrixed pharmaceutical, biotechnology, or medical device development environment.
• Comprehensive mastery of combination product regulations and design controls, including 21 CFR Part 4, 21 CFR 820.30, ISO 13485, and ISO 14971.
• Strong experience managing complex technical milestones, balancing interdisciplinary priorities, and communicating technical risks to senior leadership and partner groups.
• Mechanical engineering aptitude, statistical analysis, tolerance stack analysis, material compatibility, and mechanical testing expertise sufficient to critically review and approve technical work packages.
• Expertise facilitating and authoring system or device DFMEAs, PFMEAs, and risk-benefit analyses.
• Required technical skills include component design and engineering, controls assurance, design analysis and evaluations, design verification and testing, engineering specifications, equipment engineering and procurement, human factor engineering, medical device quality systems, packaging management, process development engineering, QMS, test method validation, and troubleshooting.

Nice to have

• Experience as a Device Technical Lead or Device Sub-Team Lead on combination product programs.
• Experience authoring and defending device constituent sections of BLA, NDA, or IND submissions and responding to formal health authority information requests.
• Experience directing external device OEMs, custom equipment automation integrators, and secondary packaging or assembly CDMOs.
• Experience with bench-top device functional testing, data analysis, and designing or facilitating in-clinic device usability studies.
• Experience developing or characterizing autoinjectors, prefilled syringes, on-body injection systems, or near-body injection systems.

Culture & Benefits

• Cross-functional and cross-divisional collaboration focused on technical excellence and disciplined root-cause problem solving.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive workplace with equal employment opportunity and accommodation support during the hiring process.

Hiring process

• Applications are accepted for the Rahway, New Jersey position through the company careers site.
• Visa sponsorship is not available.