Project Engineer, Advanced Operations

Stryker; Portage (MI); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Stock purchase plan

Job summary

A leading medical technology company in Portage, Michigan is seeking a Project Engineer for Advanced Operations. This full-time role involves process design and validation, working with cross-functional teams on product development. Responsibilities include supporting new product introductions, analyzing equipment performance, and training team members. Candidates should have a Bachelor's Degree in Engineering and 0-2 years of experience. Strong problem-solving skills are essential for success in this position.

Qualifications

• 0-2+ years of related experience required.
• Knowledge of DFM and validation techniques preferred.
• Experience in FDA-regulated industries beneficial.

Responsibilities

• Support new product and process introductions.
• Analyze and resolve complex product and process issues.
• Train manufacturing team members on compliance processes.

Skills

Independent problem-solving

Application of engineering techniques

Component selection

Ability to analyze equipment performance

Manufacturing design problem-solving

Education

Bachelor’s Degree in Engineering

Job description

Join to apply for the Project Engineer, Advanced Operations role at Stryker.

This position involves process design, development, and validation, working with a cross-functional team on new product development. The role requires independent problem-solving skills, application of engineering techniques to reduce product time to market, and adherence to regulatory, project, and cost requirements. The engineer may also provide guidance and training to team members.

Responsibilities:

• Support new product and process introductions, ensuring compliance with development procedures.
• Select components based on specifications, reliability, and regulations.
• Oversee supplier activities, including equipment implementation and troubleshooting.
• Lead/support capital acquisition activities, including equipment specification and validation.
• Analyze equipment performance, conduct tests, and lead process review meetings.
• Participate in PFMEA, Control Plan, SOP, and PPAP related to product transfers and launches.
• Support production builds at Stryker and contract manufacturer sites.
• Complete capability studies and generate inspection documentation.
• Provide status reports and progress evaluations to management.
• Train manufacturing team members and ensure GMP and safety compliance.
• Draft, review, and approve validation documentation.
• Generate and explain detailed operating procedures.
• Analyze and resolve complex product and process issues independently.
• Make decisions impacting operations and manage multiple tasks efficiently.

Requirements:

• Bachelor’s Degree in Engineering (Mechanical, Electrical, or Biomedical preferred).
• 0-2+ years of related experience.

Preferred Experience:

• Problem-solving in manufacturing/design issues, with good judgment for mechanical and structural design.
• Knowledge of DFM, statistical tools, and validation techniques.
• Understanding of manufacturing processes, materials, and product design.
• Ability to read complex engineering drawings and understand GD&T.
• Experience in FDA-regulated industries is beneficial.

Benefits include health, dental, vision, critical illness, accident, hospital indemnity, wellness programs, HSA, FSA, 401(k), stock purchase plan, insurance, and disability benefits. Stryker’s products improve healthcare outcomes worldwide. Some roles may require vaccinations depending on customer requirements.

Additional Details:

• Seniority level: Associate
• Employment type: Full-time
• Job function: Engineering and IT

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