6 days left
- Job Level
Contract Term: Permanent
Adecco are currently looking for a talented and motivated NPI Engineer who is interested in joining a multinational technologies company, to work onsite with their top medical device clients based in Cork.
This is a permanent opportunity with the company that offers an amazing remuneration and benefits package.
SUMMARY OF JOB:
Development and qualification of manufacturing processes for new product introductions as part of a global team. The successful candidate will provide the technical lead in cross-functional teams to design, set up, and qualify new processes to meet challenging project commitments in line with agreed business goals. The role will involve collaborating with global R&D teams to develop innovative and cost-effective devices and delivering highly stable and effective manufacturing processes on time.
MAIN DUTIES & RESPONSIBILITIES:
Work within the New Product Introduction team with responsibility for the project engineering-related activities, including, but not limited to the following
Provide design for manufacturing technical input to global design groups - Conduct and lead detailed product design reviews.
Lead NPI manufacturing process design, development, and process characterization activities.
Design, develop, and source tools, fixtures, and special equipment for manufacturing processes.
Lead validation strategy for Equipment and Process qualification.
Execution of Equipment and Process Validations.
Deliver stable manufacturing solutions in line with business metrics.
Lead the development and implementation of process improvements.
For new products, ensure the efficient and timely transfer of product and process knowledge to Process Engineering.
Development of capacity plans, understand constraints, develop capital plans where appropriate.
10. Project planning to deliver project(s) against agreed milestones and project scope.
11. Lead risk management activities.
Third level degree in Biomedical / Mechanical / Manufacturing Engineering or similar discipline.
3 years minimum post-graduate (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment.
Proven track record in the development, installation, and qualification of manufacturing processes, ideally in Class II / III medical devices.
Strong interpersonal and team skills.
Demonstrated ability to lead sub-teams within a project and give technical direction to fellow team members, contractors, vendors to complete tasks to a defined timeline.
Skilled in preparing documentation such as validations protocols and reports, process documentation, risk analysis documentation.
Excellent Planning & Organizing Skills including attention to detail, multi-tasking, critical thinking, and problem-solving.
Proficiency of GD&T and ASME Y14.5M 1994 / 2009 standards.
Flexible work ethic.
1. Certification from an accredited institution in Project/Program Management.
2. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDR and FDA 21 CFR 820) and other pertinent Design Control requirements.
3. Knowledge of anatomy and physiology.
4. Knowledge of orthopedic joint manufacturing processes.
SME in-process characterization and qualification.
6. Certified Six Sigma qualification.
Sounds interesting? We look forward to discussing your next career move. Apply online and a Specialist Recruiter will be making contact shortly.
Adecco Ireland is acting as an Employment Business in relation to this vacancy.
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.
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♦ The business of the Adecco Group UK & Ireland is transacted via a number of differently branded trading entities, as follows: Adecco UK Limited, Adia Technology Limited, Modis International Limited, Badenoch and Clark Limited, Ajilon (UK) Limited, Office Angels Limited, Penna plc, Pontoon Europe Limited, Roevin Management Services Limited, Spring Technology Staffing Services Limited.