Hybrid Senior Compliance Engineer, MedTech SaMD

Stryker; Portage (MI); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker is seeking a Senior Compliance Engineer to support the Smart Care portfolio, focusing on SaMD/SiMD and related hardware. The role requires deep technical judgment and leads compliance strategy across product development, certification, and lifecycle management.

Hybrid role with in-office presence in Portage, MI (minimum 3 days/week). Collaboration with Regulatory Affairs, R&D, and Marketing is essential to align compliance with market needs and classification requirements.

Qualifications

• Bachelor’s degree in Computer Science, Software/Electrical Engineering or related discipline.
• 2+ years of compliance engineering experience.

Responsibilities

• Lead product compliance strategy for new development and sustaining engineering across the Smart Care portfolio.
• Translate global regulatory requirements into design inputs, verification plans, and market access strategies.
• Drive compliance activities from concept through verification, validation and commercialization.
• Assess compliance risks and emerging requirements to support informed decisions.
• Partner with cross-functional teams to integrate compliance into system design and roadmaps.
• Define compliance test strategies, environments, and worst-case conditions for robust evaluations.
• Manage external laboratories, certification bodies, and third-party partners for global certifications.
• Provide guidance during design reviews, risk assessments, and development activities.
• Influence organizational compliance practices by supporting procedures and cross‑business initiatives.
• Collaborate with stakeholders to align strategies with user needs and market requirements.

Skills

Compliance engineering

Regulatory requirements

Cross-functional collaboration

Education

Bachelor's degree in CS/Engineering

Master's degree in CS/Engineering

Tools

Certification labs management

Medical device standards

Job description

Stryker is seeking a Senior Compliance Engineer to support the Smart Care portfolio, focusing on SaMD/SiMD and related hardware. The role requires deep technical judgment and leads compliance strategy across product development, certification, and lifecycle management.

Hybrid role with in-office presence in Portage, MI (minimum 3 days/week). Collaboration with Regulatory Affairs, R&D, and Marketing is essential to align compliance with market needs and classification requirements.