**Who We Want**
- ** Detail-oriented process improvers.
** Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
- ** Self-directed imitators.
** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- ** Strategic thinkers.
** People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
- ** Collaborative partners.
** People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- ** Motivated product launchers.
** People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
**What You Will Do**
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
Builds productive internal and external working relationships and may periodically provide guidance and train other team members.
- Essential Duties & 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.
- 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.
- 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.
- Complete capability studies for in process inspection and generate subsequent Inspection documentation.
- Conduct MSA studies for new products and new processes.
- Provide training for manufacturing team members.
- Ensure adherence to GMP and safety procedures.
- Review and approval of validation documentation.
- All other duties as assigned.
**What You Will Need**
- B.S in Mechanical Engineering or related engineering discipline;
- 5 years' experience;
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams;
- Be open minded with the ability to recognize good ideas;
- 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;
- Bilingual in English and Spanish.
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