Sr Staff Engineer, Windchill PLM

Stryker • Portage, MI

97d

About The Position

Stryker is hiring a Senior Staff Specialist, Windchill PLM in Portage, MI to lead the technical execution, development, and continuous improvement of the Windchill (onePLM) system for our Instruments Division. This role includes mentoring global Business Admins, overseeing Quality Management System (QMS) compliance with medical device regulations, and collaborating with Global Process Owners to implement and maintain quality and regulatory processes across our global systems, all within a fast-paced, innovative environment.

Requirements

• Bachelor's degree in science, engineering, business or related discipline.
• 8+ years of experience in manufacturing environment or equivalent.
• Experience in regulated environment and interaction with regulatory agencies.
• Knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

Nice To Haves

• Experience in developing and optimizing complex systems.
• Knowledge of the Quality System Regulations (21 CFR Part 820) and ISO 13485 Regulations as it relates to change management.
• Thorough knowledge and understanding of US and International Medical Device Regulations.

Responsibilities

• Lead the research, design, development, and evaluation of complex medical device systems.
• Apply advanced engineering principles and mentor others in technical concepts and practices.
• Translate user needs into system requirements and develop test architectures.
• Allocate and decompose requirements across electrical, mechanical, and software disciplines using modeling and analysis techniques.
• Guide concept phase activities and resolve complex product design challenges.
• Conduct analytical studies including trade-offs, optimizations, and performance assessments.
• Lead system integration, testing, and verification, and contribute to product risk management.
• Manage validation activities (IQ, OQ, PQ), change control, CAPA/NC actions, and ensure compliance with QMS and regulatory standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree