Senior Staff Advanced Operations Engineer GEAR EXPERTISE
Responsible for creating a work practice and environment that pushes the boundaries of conventional manufacturing & metrology. Role success will be gauged by this individual's contribution in coaching the engineering team to effectively meet and/or exceed new product metrics including product cost, process performance and time to market.
- Determines the technical objectives of engineering assignments and makes decisions regarding the direction and the results of the assignment.
- Will monitor and control progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
- Lead capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
- Will analyze equipment to establish operating data, conduct experimental test and result analysis. May lead or act as independent reviewer in process review meetings.
- Will coach and mentor others on functionally related topics.
- Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Client's new product development procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Will 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.
- Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- All other duties as assigned.
- B.S in Mechanical Engineering or related engineering discipline
- 7 or more years experience; Related masters degree with 2 or more years of experience or PhD desirable
- General Knowledge of AGMA gear standards.
- Proficient in gear design theory (spurs, helicals, spiral bevels)
- Proficient with Gear processing: Heat treat, shot peening, Hobbing, grinding, shaping, etc.
- 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 the 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 the ability to understand geometrical dimensioning and tolerancing.
- Certified in validation activities.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
- Excellent attention to detail