Project Engineer, Advanced Operations
Project Engineer, Advanced Operations
Posted on :
11-08-2025
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1 Vacancy
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Job Description
Work Flexibility: Hybrid
The Project Engineer Advanced Operations is responsible for process design development and validation while working with a diverse cross-functional team on new product development. They will independently determine and develop approaches to a variety of technical problems of moderate scope and complexity. They will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements project deadlines and product costs. They will build productive internal and external working relationships and may periodically provide guidance and train other team members.
Responsibilities:
- Provide engineering support for new product and process introductions ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
- Will select components and equipment based on analysis of specifications reliability and regulatory requirements.
- Will oversee supplier and contract manufacturer activities such as equipment implementation and process development including any necessary troubleshooting. May also include working with internal and external subject matter experts.
- May lead/support capital acquisition activity from specifying equipment contract negotiation installation and validation.
- Will analyze equipment to establish operating data conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- Participate in PFMEA Control Plan SOP and PPAP generation associated with product transfers and launches.
- Lead/support production builds at both Stryker and contract manufacturer sites.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Provides on-going status reports including periodic reviews progress and evaluation of results to management.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Draft execute review and approval of validation documentation.
- Must be able to generate follow and explain detailed proposals and operating procedures (i.e. assembly instructions inspection procedures and capital project proposals).
- Must be able to analyze and correct complex product and/or process issues using independent judgement.
- Must be able to routinely make decisions that affect immediate operations.
- Must be able to plan organize and implement multiple concurrent tasks.
What you need:
- Bachelors Degree in Engineering; Mechanical Electrical or Biomedical preferred.
- 0-2 years related years of experience.
Additionally you should have experience:
- 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 (DFM) related statistical tools and validation/verification techniques.
- Good knowledge of manufacturing processes materials product and process design.
- Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial.
Employment Type
Full-Time
Key Skills
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