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Advanced Manufacturing Specialist
3 weeks ago
This role involves executing the innovation and development of assigned project elements with a focus on manufacturing process, technology and procedures required for the manufacture of new products.
- Utilize latest engineering techniques to minimize 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 that all activities are completed and documented in accordance with established procedures.
- Ensure quality of process and product as defined in the appropriate operation and material specifications.
- Collaborate with quality engineers to develop component specific testing and inspection protocols.
- Support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.
- Conduct analysis of equipment to establish operating data, experimental testing 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.
Required Skills and Qualifications
The ideal candidate should possess a B.S in Mechanical Engineering or related engineering discipline with 2 or more years' experience.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Excellent analytical skills, ability to plan, organise and implement concurrent tasks.
- Good knowledge of manufacturing processes, materials, product and process design.
- Ability to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
- Excellent attention to detail.
Benefits
This role offers a dynamic and results orientated team environment, with opportunities for professional growth and development.
