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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.
Responsibilities
* Determine the technical objectives of engineering assignments and make decisions regarding the direction and results of the assignment.
* Monitor and control progress of work, ensuring sound application of engineering principles and proper use of policies and procedures.
* Lead capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
* Analyze equipment to establish operating data, conduct experimental tests, and analyze results. May lead or act as an independent reviewer in process review meetings.
* Coach and mentor others on functionally related topics.
* Provide ongoing status reports, including periodic reviews of progress and evaluation of results to management.
* Support new product and process introductions, ensuring activities are completed and documented per the company's development procedures.
* Ensure quality of process and product as defined in operation and material specifications.
* Select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Collaborate with quality engineers to develop testing and inspection protocols.
* Participate in PFMEA, Control Plan, SOE/MAP, and PPAP generation related to product transfers and launches.
* Adhere to GMP and safety procedures.
* Operate with latitude for unreviewed actions or decisions.
* Review and approve validation documentation.
Qualifications/Work Experience Preferred
* At least 4 years of experience.
* Proven track record of working effectively in a team environment.
* Excellent interpersonal skills—able to express ideas and collaborate with multidisciplinary teams. Open-minded with the ability to recognize good ideas.
* Innovative thinker—able to envision new and improved ways of doing things.
* Experience in complex problem solving related to manufacturing and design issues. Good instincts and sound judgment for mechanical and structural design.
* Good understanding of Design for Manufacturing (DFM), statistical tools, and validation/verification techniques.
* Excellent analytical skills, with the ability to plan, organize, and implement concurrent tasks.
* Strong knowledge of manufacturing processes, materials, and product and process design.
* Ability to read and interpret complex engineering drawings, including geometrical dimensioning and tolerancing.
* Familiarity with validation activities.
* Experience in FDA-regulated or similar regulated industries is beneficial.
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