Job Title: Senior Operations Engineer
Senior Operations Engineer is responsible for creating a work practice and environment that pushes the boundaries of conventional manufacturing & metrology.
Role Responsibilities:
1. Determine technical objectives of engineering assignments and make decisions regarding direction and results of the assignment.
2. Monitor and control progress of work ensuring sound application of engineering principles and appropriate use of policies and procedures.
3. Lead capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
4. Analyze equipment to establish operating data, conduct experimental tests and result analysis.
5. May lead or act as independent reviewer in process review meetings.
6. Coach and mentor others on functionally related topics.
7. Provide on-going status reports including periodic reviews progress and evaluation of results to management.
8. Provide engineering support for new product and process introductions, ensuring all activities are completed and documented in accordance with Stryker new product development procedures.
9. Ensure quality of process and product as defined in the appropriate operation and material specifications.
10. Will select components and equipment based on analysis of specifications, reliability and regulatory requirements.
11. Work with quality engineers to develop component specific testing and inspection protocols.
12. Participate in PFMEA, Control Plan, SOE/MAP and PPAP generation associated with product transfers and launches.
13. Ensure adherence to GMP and safety procedures.
14. Operate with appreciable latitude for unreviewed action or decision.
15. Review and approval of validation documentation.
16. Qualifications/Work Experience Preferred:
* 4 or more years experience.
* Proven track record of working in a team based environment.
* Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
* Be open minded with ability to recognize good ideas.
* Innovative thinker - should be able to envisage new and better ways of doing things.
* 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.
* Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
* Good knowledge of manufacturing processes, materials, product and process design.
* Must be able to read and interpret complex engineering drawings and have ability to understand geometrical dimensioning and tolerancing.
* Familiar with validation activities.
* Experience in an FDA regulated or regulated industry beneficial.
* Excellent attention to detail.
Key Qualifications:
* 4 or more years experience
* Proven track record of working in a team based environment
* Excellent interpersonal skills
* Open minded
* Excellent analytical skills
* Good instincts and sound judgement
* Good understanding of DFM and validation/verification techniques
* Ability to read and interpret complex engineering drawings
* Knowledge of manufacturing processes, materials, product and process design
Travel Percentage: 20%