Operations Project Engineer at Mallinckrodt Pharmaceuticals in Albany, New York

Posted in Other 5 days ago.

Job Description:

Job Title

Operations Project Engineer


JR000011387 Operations Project Engineer (Open)


US Specialty Brand Headquarters - USA501

Additional Locations

Albany, NY

Job Description


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.

Essential Functions

  • 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.

Minimum Requirements

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


  • 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

Organizational Relationship/Scope:

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:

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.