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 appropriate use of policies and procedures.
Lead capital acquisition activities from specifying equipment, contract negotiation, installation, to 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 all activities are completed and documented according to the company's new product development procedures.
Ensure quality of process and product as defined in operation and material specifications.
Select components and equipment based on specifications, reliability, and regulatory requirements.
Collaborate with quality engineers to develop component-specific 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 action or decision.
Review and approve validation documentation.
Qualifications/Work Experience Preferred
Four or more years of experience.
Proven track record of working in a team-based environment.
Excellent interpersonal skills—able to express ideas and collaborate effectively with multidisciplinary teams.
Open-minded with the ability to recognize good ideas.
Innovative thinker—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 judgment for mechanical and structural design.
Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
Excellent analytical skills, with the ability to plan, organize, and implement concurrent tasks.
Good knowledge of manufacturing processes, materials, product, and process design.
Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
Familiar with validation activities.
Experience in an FDA-regulated or regulated industry is beneficial.
Excellent attention to detail.
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