Sr Staff Engineer, Windchill PLM

Work Flexibility: Hybrid or Onsite

Senior Staff Specialist, Windchill PLM

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.

What you will do:

• 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 you will need:

Required:

• 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.)

Preferred:

• 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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.