Senior Development Engineer

🚀 Hiring: Senior Development Engineer – Medical Device Design Controls

🏢 Aequor Technologies LLC (for our client)

📍 [Warsaw] | Hybrid – 3 days onsite | 3–5 yrs experience

Help integrate a new acquisition into our client's global design controls and risk management processes, with a focus on orthopedic infection prevention and treatment.

🔧 What You'll Do

• Harmonize design controls and risk management procedures with global processes

• Author remediation protocols and support integration strategy decisions

• Author and review design control, risk management, and regulatory documentation

• Lead feasibility workstreams and smaller projects

• Coordinate deliverables with cross-functional teams and external partners

✅ What You Bring

• Bachelor's in Engineering + 3–5 yrs in medical device product development/NPI

• Strong Design Control experience (key requirement)

• DHF experience, including DHF remediation

• Software system design controls: SaMD or software in medical devices

• Hands-on prototype development

• ISO 13485, ISO 14971, BS EN 62304, IEC 62366-1

• Engineering statistics: sample size, DOE, hypothesis testing

• Strong cross-functional collaboration; able to hit the ground running

⭐ Nice to Have

• Orthopedic experience (preferred, not required)

• Biomaterials, antimicrobials, coatings, or local drug delivery

• Minitab

✈️ Travel: ~25% may be required (TBC)

📩 Apply now or message me to learn more.

#MedicalDevices #DesignControls #DHF #SaMD #IEC62304 #ISO14971 #NPI #Hiring

Aequor Technologies LLC is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.