Senior Process Engineer, Advanced Operations
Stryker GmbH
Date de publication :
28 septembre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Portage
Who we want:
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
- Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What you will do:
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with Stryker’s new product development procedures
- Ensure quality of process and product as defined in the appropriate operation and material specifications
- Select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.
- Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Work with quality engineers to develop component specific testing and inspection protocols
- Analyze equipment to establish operating data and conduct experimental test and result analysis
- Lead process review meetings
- Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches
- Complete capability studies for in process inspection and generate subsequent inspection documentation
- Conduct process validation and MSA studies for new products and new processes
- Work in a hands-on manner at the manufacturing site to lead the implementation of new processes as specified in development
- Provide training for manufacturing team members
- Ensure adherence to GMP and safety procedures
- Review and approval of validation documentation
What you need:
- Bachelor’s degree in engineering required
- 2+ years of applicable work experience required
- Specialization or work experience in plastics or polymers
- Working knowledge of PFMEA required
- Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
- Good knowledge of manufacturing processes, materials, product and process design required
- Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
- CAD experience
Preferred skills:
- Experience in R&D, new product development, or process design
- Injection molding process development experience
- Experience in an FDA regulated or regulated industry
- Experience with plastic assembly (eg. adhesives, joining methods, welding)
- Ability to read and interpret complex engineering drawings and can 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
- Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques
- CAD experience
- 3D printing experience
Contact
Stryker GmbH