Engineering, Operations Manager, Regulatory Compliance Specialist

Senior Engineering Project Manager

Location:

Plymouth, MN, US

Workplace Type:
Hybrid

At STERIS, we help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

The Senior Project Manager will lead cross‑functional teams within STERIS’s Healthcare Reprocessing business to deliver innovative capital and consumable products that support patient safety and operational excellence. This role manages the full product development lifecycle, from concept through validation, manufacturing transfer, and launch, ensuring products meet customer, regulatory, and business requirements. With visibility across global, strategic programs, the Senior Project Manager drives alignment, solves problems, and keeps projects on track using strong planning, communication, and leadership skills.

Ideal candidates bring experience in regulated product development, particularly in medical devices, and a background in new product development, engineering, or manufacturing. This role is key to advancing STERIS’s mission and bringing high‑impact reprocessing solutions to market.

• Partner with Product Management on business cases and roadmap alignment.
• Lead cross‑functional planning and execution of roadmap products, ensuring compliance with NPD and Design Control processes.
• Manage one large complex project and one medium project from concept through launch, owning schedules, budgets, and stage‑gate deliverables.
• Monitor progress, risks, dependencies, and budgets while driving timely decisions, issue resolution, and continuous improvement.
• Lead communication and coordination across R&D, Quality, Regulatory, Marketing, and Operations to maintain transparency on milestones and risks.
• Oversee resource coordination and conduct regular status meetings and technical reviews.
• Ensure smooth transition from development to manufacturing and launch, proactively managing contingency plans.
• Travel up to 10%.

• A Bachelor’s degree.
• 6+ years’ experience in Engineering program or project management associated with product development in a medical device or a regulated industry.
• Experience in more than one of the following disciplines:
  New Product Development, R&D Engineering, Manufacturing.
• Experience leading projects from initial concept, through development and verification/validation testing, and into Manufacturing. Ability to balance customer, manufacturing, business, and regulatory requirements to expedite launch of the right product to market.
• Demonstrated proficiency in program management tools and procedures for setting and tracking performance, quality, time and cost; strong planning and organization skills required.

• Strong project/program management skills, including planning, tracking performance, quality, timelines and costs; PMP a plus.
• Proven leadership abilities in conflict resolution, negotiation, and driving results.
• Effective at leading and collaborating in a matrixed, cross‑functional environment (e.g., Legal, Regulatory, Operations, Procurement, Clinical, Marketing, Quality).
• Excellent interpersonal and influence skills with experience managing multidisciplinary teams.
• High attention to detail with strong follow‑through to proactively identify and prevent issues.
• Excellent communication (written, verbal and executive presentation) skills.
• Successful track record managing projects through the medical device PDP process, delivering on schedule and budget.
• Strong analytical skills and ability to make data‑driven decisions across functional areas.
• Interest in applying AI tools to automate or enhance project management tasks.

• Market‑competitive pay.
• Extensive paid time off and additional holidays.
• Excellent healthcare, dental and vision benefits.
• Long‑/short‑term disability coverage.
• 401(k) with company match.
• Maternity and paternity leave.
• Additional add‑on benefits/discounts for programs such as pet insurance.
• Tuition reimbursement and continued education programs.
• Excellent opportunities for advancement in a stable long‑term career.

Pay range for this opportunity is $120,000 - $134,000. This position is eligible for bonus participation.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.