Senior Compliance Engineer, Digital Health (Hybrid)

Stryker Corporation; Portage (MI); Hybride; USD 78 000 - 130 000; Plein temps

Résumé du poste

Stryker Corporation in Portage, Michigan, is seeking a Senior Compliance Engineer to lead product compliance for the Smart Care portfolio. This hybrid role involves translating global regulatory requirements into design inputs and verification plans, while coordinating with development teams and regulatory bodies.

The role requires strong knowledge of medical device standards and hands-on experience with certifications, risk assessment, and cross-functional collaboration in a fast-paced

Qualifications

• Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline.
• 4+ years of compliance engineering experience.
• Master’s degree in related field preferred.
• Experience with product safety regulatory certifications (IEC + FCC + others).

Responsabilités

• Lead product compliance strategy across the Smart Care portfolio.
• Translate regulatory requirements into design inputs and test plans.
• Manage external laboratories and regulatory submissions.
• Collaborate with R&D, Regulatory Affairs and Marketing to align strategies.

Connaissances

Compliance engineering

Regulatory affairs

Digital health

Cross-functional collaboration

Formation

Bachelor’s degree in Computer Science/Software or Electrical Engineering

Master’s degree (preferred)

Outils

Certification laboratories management

Regulatory standards knowledge

Description du poste

Stryker Corporation in Portage, Michigan, is seeking a Senior Compliance Engineer to lead product compliance for the Smart Care portfolio. This hybrid role involves translating global regulatory requirements into design inputs and verification plans, while coordinating with development teams and regulatory bodies.

The role requires strong knowledge of medical device standards and hands-on experience with certifications, risk assessment, and cross-functional collaboration in a fast-paced