Process Development Engineer
2 weeks ago
This position plays a key role in the development of new products, focusing on design for manufacturability and the implementation of manufacturing processes, test methods, and equipment.
Key Responsibilities:- Own the design, development, implementation, and validation of manufacturing processes for new products.
- Lead project meetings and reviews with multi-functional team members to supervise project status and optimally follow up on action items.
- Connect with multi-functional team members and suppliers to understand and resolve product process and equipment specifications.
- May supervise and own the career development of technicians and/or engineers.
- Document process development, including manufacturing procedures, protocols, and reports.
- Develop and maintain a broad knowledge of product design, manufacture, and assembly techniques.
- Estimate resource requirements, workload assignment, production times for manufacturing processes.
- Train technicians, engineers, operations, and quality assurance on new design and process development and test methods.
- Lead the manufacturing site selection process based on the evaluation of internal manufacturing sites, suppliers, and/or contract manufacturers.
- Participate in or create and control a project budget (expense and/or capital expenditure).
- Participate as an authority and/or lead design and technology transfers to manufacturing.
- Shown hands-on technical aptitude.
- Strong written, communication, and interpersonal skills.
- Ability to lead multi-functional teams.
- Ability to analyze data, interpret results, and write reports.
- Ability to build and implement project plans.
- Basic tooling, design, and drafting knowledge.
- Experience with process validation (IQ, OQ, PQ).
- Solid understanding of DOE and other statistical methods.
- Knowledge of cGMP and GLP.
- Training in LEAN, Six Sigma, or Design for Six Sigma.
- Experience in design and technology transfers.
- PMO certification.
Minimum B.S. degree in an engineering discipline.
Minimum of 6 years of industrial experience in process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 4 years or Ph.D. degree with 3 years, medical device or equivalent industry experience).
Work Environment:This role requires working in a team-oriented, fast-paced environment.
BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
In some locations, testing for COVID-19 may be available and/or required.
Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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