Senior Staff Engineer, Advanced Operations

Stryker; Wisconsin; On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker in Portage, MI is seeking a Senior Staff Process Engineer, Advanced Operations to shepherd new surgical product designs from R&D into production, with a focus on transfer molding and related process technologies.

You will lead design transfer, define specs, run capability studies, select equipment, and guide validation activities, ensuring GMP compliance and high-quality, reliable manufacturing. This onsite role requires a bachelor's in engineering and 6+ years of experience.

Qualifications

• Bachelor’s degree in engineering.
• 6+ years of manufacturing 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 dimensioning 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.

Responsibilities

• Design Transfer: Support new product and process introductions, ensuring adherence to Stryker's new product development protocols, with a focus on plastic injection molding.
• Process & Quality Assurance: Guarantee process and product quality by defining and adhering to specifications, conducting capability studies, and generating inspection documentation.
• Equipment & Component Selection: Evaluate components and equipment based on specifications, reliability, and regulatory requirements, and collaborate with quality engineers to develop testing protocols.
• Capital Acquisition: Lead activities from equipment specification and negotiation to installation and validation.
• Problem Solving: Conduct root cause analyses, process reviews, and experimental tests, leveraging statistical and validation techniques.
• Documentation & Compliance: Create and approve validation documentation, ensuring compliance with GMP and safety standards.
• Team Training: Provide training to manufacturing team members on new processes and technologies.

Job description

Work Flexibility: Onsite

As a Senior Staff Process Engineer, 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.

What you will do:

• Design Transfer : Support new product and process introductions, ensuring adherence to Stryker's new product development protocols, with a focus on plastic injection molding.
• Process & Quality Assurance : Guarantee process and product quality by defining and adhering to specifications, conducting capability studies, and generating inspection documentation.
• Equipment & Component Selection : Evaluate components and equipment based on specifications, reliability, and regulatory requirements, and collaborate with quality engineers to develop testing protocols.
• Capital Acquisition : Lead activities from equipment specification and negotiation to installation and validation.
• Problem Solving : Conduct root cause analyses, process reviews, and experimental tests, leveraging statistical and validation techniques.
• Documentation & Compliance : Create and approve validation documentation, ensuring compliance with GMP and safety standards.
• Team Training : Provide training to manufacturing team members on new processes and technologies.

What you need:

• Bachelor’s degree in engineering
• 6+ years of manufacturing engineering or process engineering experiencerequired
• Expertise in plastic injection molding, polymers, and plastic assembly methods (e.g., adhesives, welding)
• Ability to read and interpret complex engineering drawings and can understand geometrical dimension andtolerances
• 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/verificationtechniques

$102,600 - $171,000 USD Annual

Travel Percentage: 20%

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.