Great role to become a key member of an NPI Engineering project team to develop, qualify and launch a manufacturing process.
Key member of an NPI Engineering project team to develop, qualify and launch a manufacturing process capable of repeatedly making new products to safety, quality, service and cost standards.
- Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners.
- Lead NPI development requirements and work with cross functional teams.
- Provide design for manufacturing technical input to global design groups to minimise lifecycle cost.
- Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost).
- Deliver stable manufacturing solutions in line with stability metrics process.
- Management of R&D test parts and sample requests.
- Conduct detailed product design reviews.
- Development of advanced manufacturing processes to lean guidelines.
- Manage risk management and validation lifecycle for new process or process changes.
- Planning and execution of verification and validation activities, including:
- Generation of Validation Protocols and Reports.
- Execution of Equipment Validations (IQs/OQs) and subsequently Process Validation (OQ / PQs).
- Direct PFMEA studies and lead risk assessment effort for overall process.
- Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk.
- Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term.
- Provide timely and accurate reporting on project activities.
- All other duties as directed by direct manager.
RELATED QUALIFICATIONS AND EXPERIENCE REQUIREMENTS:
- Third level degree in Mechanical, Manufacturing, Production Engineering or similar discipline.
- Minimum of three (3) years in product / process development, ideally in Class II / III medical devices.
- Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
- Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
- Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
- Flexible work ethic.
- Certification from an accredited institution in Project/Program Management (Desirable)
- Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements (Desirable)
- Proficiency of GD&T and ASME Y14.5M 1994 standards (Desirable)
- Knowledge of anatomy and physiology (Desirable)
- Knowledge of manufacturing processes (Desirable)
WHAT ARE WE OFFERING YOU?
- 12 Month Contract position (39 Hours per week)
- Pay rates per hour negotiable, depending on experience
- Strong culture of continuous improvement and innovation
- Subsidised canteen
- Free parking, gym and classes
- Sports and Social activities
Morgan McKinley is acting as an Employment Business in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.