Staff Process Development Engineer - Ireland
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- Our company is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better.
- The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
- Our products and services are available in over 100 countries. All 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.
- 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.
Key Areas of Responsibility
- 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 analyse 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 company 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.
Qualifications Knowledge Skills
- B.S in Mechanical Engineering or related engineering discipline with 6 or more years’ experience; Related masters degree with 2 or more years of experience or PhD may be desirable.
- 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 recognise 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, organise and implement concurrent tasks.
- Excellent working knowledge of manufacturing processes, product/process design and engineering materials.
- Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Certified in validation activities.
- Green or Black Belt 6 Sigma qualifications an advantage.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
- Excellent attention to detail.