
Advanced Manufacturing Professional
6 days ago
This is an exciting opportunity for a skilled Process Engineer to join our team and contribute to the development of innovative manufacturing processes.
- Execute projects that involve the innovation and development of assigned elements with an emphasis on manufacturing process, technology, and procedures required for new product manufacture.
- Apply latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Key Responsibilities:
- Provide engineering support for new product and process introductions, ensuring all activities are completed and documented in accordance with new product development procedures.
- Ensure quality of process and product as defined in appropriate operation and material specifications.
- Assist in selecting components and equipment based on analysis of specifications, reliability, and regulatory requirements. Collaborate with quality engineers to develop component-specific testing and inspection protocols.
- Support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
- Analyze equipment to establish operating data, conduct experimental tests, and result analysis. Lead 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.
- Perform other duties as assigned.
Requirements:
- Bachelor's degree in Mechanical Engineering or related engineering discipline with 2 or more years' experience.
- Self-starter with efficient work methods, analytical skills, problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
- Able to work in a fast-paced, dynamic, and results-oriented team environment.
- Excellent interpersonal skills to express ideas and collaborate effectively with multidisciplinary teams.
- Innovative thinker able to envisage new and better ways of doing things.
- Excellent analytical skills to plan, organize, and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product, and process design.
- Able to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
- Experience in FDA-regulated or regulated industries beneficial.
- High level of PC skills required.
- Excellent attention to detail.
About Us:
We are a leading manufacturer of innovative products, and we are committed to excellence in everything we do. We offer a collaborative and dynamic work environment, opportunities for growth and development, and a competitive compensation package.
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