JR000011090 Sustaining Engineer (Field, North East) (Open)
Field Based Location - USA082
The Sustaining Engineer role will provide support to the manufacturing team in the technical areas of design, sustaining, manufacturing, and quality engineering to help achieve the business goals for quality, compliance, customer satisfaction, cost and safety. As a key member of the Product Support Team this role will manage sustaining projects from inception to completion including scope, schedule, reporting and documentation.
This position is responsible for key initiatives supporting the business objectives and operational goals for quality improvements, customer satisfaction, cost reductions, supplier initiatives, new product introductions, obsolescence and product safety. As an active member of the product life cycle management team, this professional will have a high level of agility and resiliency with the ability to quickly move between projects and assignments, while maintaining the highest degree of engineering performance. Working in a cGMP environment related to medical devices, this position must possess a constant focus on patient safety and customer satisfaction.
Leadership of small teams including internal and external resources
Management of projects related to support of current products and/or new product development support
Process Change Orders, CAPA's, Purchase Orders, Invoices as required.
Process/Product changes to resolve field product problems.
Process/Product changes to comply with regulatory requirements.
Process/Product changes to resolve quality problems.
Process/Product changes due to material obsolescence.
Conducting component research/selection and recommendation of suppliers.
Act as the Operations representative on the Product Support Team and use the project tracking system as required.
Lead and/or participate in technology transfers, new product launches, validation activities, CIP's, etc with the CMO and internal cross functional teams including Device Engineering, Regulatory Affairs and Quality departments.
Work with internal and external teams to coordinate changes to materials, processes and equipment.
Education / Experience / Skills:
4-year degree in a Science or Engineering discipline.
Minimum 5 years of experience working with complex medical devices
Qualifications/Certifications in any of the following is desirable: Lean Manufacturing/Six Sigma, Supply Chain, Project Management.
High degree of interpersonal, influencing skills, negotiation and team skills.
Complex problem solving skills.
Understanding of cGMP requirements, ISO 13485 and other regulatory requirements.
Experience developing, delivering, deploying and maintaining medical devices under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems is preferred
Advanced level mastery of both business/technical applications (MS Office Suite), Minitab desired.
Knowledge of extracorporeal blood processing systems (collection, apheresis, dialysis, cardiac assist, etc.) is desirable
Possesses a working knowledge of regulatory agency requirements
Advanced level mastery of both business/technical applications.
6 and/or Lean Certification and expertise is desired. Use of Lean Six Sigma tools in continuous improvement projects.
Experience driving continuous improvement in manufacturing is desired.
The ability to prioritize tasks to meet deadlines
Ability to start up and lead cross functional teams in the resolution of short term issues or sustained performance for longterm goals.
Excellent organizational, written and verbal communication & negotiation skills desired.
Experience with injection mold tool design, implementation and maintenance is preferred
Experience with Ultrasonic/RF Welding, Solvent bonding, Medical device assembly is desired
Interpreting product and manufacturing requirements
Automatic/semi-automatic test equipment systems
Familiar with EU MDR requirements
This position routinely interacts with areas responsible for product performance, including but not limited to Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues. This is an advanced level role requiring in depth product and therapy understanding across multiple use cases. In-depth understanding of key stakeholders needs is essential, as this role will often interact cross functionally as a technical resource.
Travel: 20% - 60%, Ability to travel by air, car, etc.
Travel will be required to visit CMO and supplier sites and Mallinckrodt locations. Locations include Upstate NY, Vermont, New Jersey, North Carolina, Wisconsin and Ireland
This may be a field based position that will require a home office setup.