Senior Development Engineer

Aequor; Warszawa; Hybrid; PLN 190,000 - 320,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Aequor is seeking a Senior Development Engineer - Medical Device Design Controls in Warsaw, with hybrid work arrangement (3 days onsite). The role focuses on integrating a new acquisition into global design controls and risk management, particularly for orthopedic infection prevention and treatment.

You will harmonize global processes, author remediation protocols, and lead design control documentation while coordinating cross-functional teams and external partners.

Qualifications

• Extensive design controls experience in medical devices.
• DHF experience, including remediation.
• Experience with SaMD or software in medical devices and regulatory standards.
• Familiar with ISO 13485, ISO 14971, BS EN 62304, IEC 62366-1.
• Strong cross-functional collaboration and ability to hit the ground running.

Responsibilities

• Harmonize design controls and risk management 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.

Skills

Design controls

DHF remediation

SaMD software

ISO 13485

ISO 14971

BS EN 62304

IEC 62366-1

Engineering statistics

Cross-functional collaboration

Job description

Hiring: Senior Development Engineer - Medical Device Design Controls

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

• - Strong Design Control experience (key requirement)
• - DHF experience, including DHF remediation
• - Software system design controls: SaMD or software in medical devices
• - 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)

#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.