The Operations Project Engineer will support the redesign of legacy device by working with project team to accomplish operations deliverables. This will require the ability to work cross functionally with internal and external partners. The project engineer will work with the Device Engineering team from design inception to implementation at CMO. This will include component sourcing, supplier selection, design inputs, DFM, verifications/validations, test equipment development for components, assemblies and devices.
This role is responsible for operations related product development activities for a complex medical device. Accountable to defined product requirements, support the development of hardware architectures, design system framework, to ensure requirements are satisfied throughout the development process ensuring compliance with quality systems. The candidate will promote designs geared toward efficient manufacturing transitions and lead component supplier selections.
This role will also 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.
Management of projects related to support of current products and/or new product development support
Process Change Orders, CAPA's, Purchase Orders and Invoices as required.
Process and procedures to comply with regulatory requirements
Manufacturing strategies to introduce new products
Resolving system-level design/production problems
Conducting component research/selection and recommendation of suppliers.
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.
Development of functional medical device systems while ensuring alignment with chosen manufacturing assembly process development.
Develop and deliver technical presentations to internal stakeholders including costs of features, schedule and overall business impact.
Education / Experience / Skills:
4-year degree in appropriate engineering discipline. Significant work experience in medical device may be substituted in lieu of degree.
Minimum 5 years of experience in complex medical device design, sustaining or manufacturing engineering role
High degree of interpersonal, influencing skills, negotiation and team skills. High degree of supervision/project coordination skills. Complex problem solving skills.
In depth understanding of cGMP requirements, ISO 13485 and other regulatory requirements.
Experience in managing small groups of engineers
Experience managing small to medium-sized engineering projects including internal and external resources
Experience with CAPA's, Customer complaints and ability to process change
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
Experience in managing change for medical device
6 and/or Lean Certification and expertise is desired including Root Cause Analysis. Use of Lean Six Sigma tools in continuous improvement projects.
Interpreting product and manufacturing requirements
Experience driving continuous improvement in manufacturing is desired
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 long-term 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 positon routinely interacts with colleagues, including those responsible for but not limited to Product Performance, Device Quality, Post Market Surveillance, Device Development, Materials Management and external resources required to appropriately address all product life cycle issues and new product introduction. This is an advanced level role requiring in-depth product and therapy understanding across multiple use cases. In-depth understanding of key stakeholder needs is essential, as this role will often interact cross- functionally as a technical resource.
Working conditions are those typically found in a final assembly and test environment for medical devices. Work spaces include office environment, on-site at suppliers and in multiple MNK locations.
US based - Some travel both domestic and international will be required up to 20%. Travel will be required to visit CMO and supplier sites as well as 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.
Ireland based - Some travel both domestic and international will be required up to 20%. Travel will be required to visit CMO and supplier sites as well as Mallinckrodt locations. Locations include Castlerea manufacturing and other EU region suppliers. This may be a field based position that will require a home office setup.