Senior Staff Engineer, Advanced Operations

About the role

As a Senior Staff Process Engineer in Advanced Operations, you will play a pivotal role in transferring cutting-edge surgical product designs from R&D into production. This position requires expertise in process development, specifically with transfer molding and related technologies. Collaborating with cross-functional teams, you will ensure the seamless launch of high-quality products, enhancing both patient outcomes and operational efficiency. This is an onsite position in Portage, MI.

Responsibilities

• Support new product and process introductions, ensuring adherence to Stryker’s new product development protocols, with a focus on plastic injection molding.
• Guarantee process and product quality by defining and adhering to specifications, conducting capability studies, and generating inspection documentation.
• Evaluate components and equipment based on specifications, reliability, and regulatory requirements, and collaborate with quality engineers to develop testing protocols.
• Lead capital acquisition activities from equipment specification and negotiation to installation and validation.
• Conduct root cause analyses, process reviews, and experimental tests, leveraging statistical and validation techniques.
• Create and approve validation documentation, ensuring compliance with GMP and safety standards.
• Provide training to manufacturing team members on new processes and technologies.

Requirements

• Bachelor’s degree in engineering.
• 6+ years of manufacturing engineering or process engineering experience.
• Expertise in plastic injection molding, polymers, and plastic assembly methods (e.g., adhesives, welding).
• Ability to read and interpret complex engineering drawings and understand geometrical dimension and tolerances.
• Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
• Good instincts and sound judgement for mechanical and structural design.
• Ability to lift up to 20 pounds to move equipment.
• Ability to work with and assemble small objects and component parts.
• Ability to operate small hand tools, inspection equipment, and other office equipment.

Preferred Skills

• Tooling design experience.
• Experience in R&D, new product development, or process design.
• Experience in an FDA regulated or regulated industry.
• CAD experience.
• Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques.

Pay

$102,600 - $171,000 USD Annual

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.