Johnson and Johnson Med Tech is now recruiting for a Senior Manufacturing Engineer to work fully on-site at our facility in Raynham, MA.
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As part of Johnson and Johnson's - DePuy Synthes manufacturing strategy we are increasing Global Manufacturing capacity within the DPS Orthopedic franchise. As part of that initiative, we are now recruiting for a Senior Manufacturing Engineer to deliver on project requirements for the Foundry capacity expansion for specific product platforms in the Raynham, MA.
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This role will be responsible for driving engineering work in the areas of process development, tool design and procurement, validation, machine programming, machinery & equipment acquisition, continuous improvement and other duties associated with engineering support of production, leading to the successful achievement of program goals and objectives. The scope of this position will include both project delivery as well as ensuring knowledge transfer to developing manufacturing site staff and will work in collaboration with the existing DPS functional organizations to ensure standardization and the implementation of Best-in-Class practices.
Key Role Responsibilities:
- Responsible for planning, developing, and delivering processes associated with development of new foundry tooling, new equipment and processes.
- Participates in highly complex engineering projects with an extensive multi-functional team. This includes developing and completing to the plan and schedule and meeting the goals and objectives of the project.
- Collaborate with functional partners, internal and external, to ensure that technical, validation and regulatory strategies are implemented in an efficient and compliant manner and at an appropriate risk level to project plans.
- Provides direction and technical support regarding tooling and equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.
- Performs assignments that have complex objectives requiring application of standard engineering techniques, procedures, and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing.
- Writes and implements engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation) as well as develops and implements manufacturing and inspection procedures.
- Exercises independent judgment on significant details of work and makes selections and adaptations of engineering alternatives.
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, equipment and their manufacture.
- Ensure that all project activities are conducted in line with procedures and controls outlined in the QMS and that the quality and performance of the product conforms to specified standards and in compliance with the recognized Regulatory Standards for relevant markets.
Qualifications
Required Skills:
- Experienced in a Medical Device and/or supervised manufacturing work environment
- Minimum four (4) years of relevant professional work experience
- Strong interpersonal and communication skills & demonstrated ability to operate as part of a team (written and oral).
- Working knowledge and strategy in drafting and performing process/equipment validations (IQ, OQ, PQ, CSV, TMV)
- Track record of innovation and adaptability in project execution, with strong problem-solving skills
- Proven competence to evaluate communicate and act upon significant risks, demonstrating leadership of the high standards of quality and compliance
- Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results
Preferred Skills:
- Hands-on experience with foundry casting processes, machining processes, metal finishing processes, laser processing or production automation.
- Ability to read and interpret blueprints of parts and machinery with Geometric Dimensioning and Tolerancing (GD&T)
- E2E supply chain knowledge and experience
- Project management experience
- Knowledge of statistical data analysis tools (e.g. Minitab) preferred
Education/Qualifications:
- Minimum of a Bachelor's degree or University degree required; focused degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering or in a supply-chain related field preferred.
Other:
- This role may require up to 20% of domestic & international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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