Senior Principle Process Engineer

Description

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

Abiomed's Global Automation Engineering Group showcases innovative technical masters, world-class technologies and solutions that “power” the quality and performance of Abiomed’s heart pumps! The Sr. Principal Process Engineer provides engineering and technical resource expertise to improve the group’s contribution to company performance.

This role serves as one of the leaders of the technical community, working across all technical functions, both internally and externally, developing new technologies and processes for existing and future product production. This role is responsible to design, build and implement the most efficient manufacturing controls hardware and software to meet the automation needs of a very dynamic and technically complicated business.

Abiomed, a division of J&J Medical Device, is an innovative medical device company focused on recovering hearts and saving lives! Through its Impella pump systems, Abiomed seeks to grow its production capabilities, automation capabilities and control systems.

The Danvers site is a global business and product development hub that co-locates all commercial and technical fields. This offers a broad range of career and experience building opportunities.

Key Responsibilities

The successful candidate will primarily focus on the development and delivery of robust, in-control, on-target, and capable manufacturing processes. The Senior Principal Process Engineer role is relevant for various fields and scope, and in this case is targeting support for Global Automation Engineering with the design, development, specification and implementation of all end-to-end manufacturing equipment and processes. This includes the development of automated equipment processes; end-to-end continuous improvement efforts, supply chain capacity expansion support, technology transfers and new product / process development.

Partner with the broader technical community during early program phases to identify potential process capability issues, prioritize validation plans for relevant product specifications, and develop source of variation learning plans for related process development workLead and / or participate in the definition of the overall acceptance testing plan for assigned projectsThe individual will be heavily involved and take ownership in assuring process robustness for the IQ, OQ, FAT, SAT, PQ and PPQ efforts for new assembly and packaging technologies and/or transferring technologies to new factory sitesProvide hands on execution of aligned test plans, creation of test plans and ability to implement plans

Qualifications

Education

Bachelor of Science or equivalent experience in Mechanical Engineering or like engineering field

Experience and Skills

Required

In depth and proven knowledge in the development and qualification of manufacturing processes for discrete component assembly and processes is a requiredA demonstrated thorough, focused and hands-on approach to insuring product produced at scale meets all elements of design intent, thus enabling the execution of robust manufacturing processes is requiredMastery of process development methodology that collects knowledge and identifies gaps, points out non-value added processes, builds reliability, reduces startup costs, improves quality and reduces development cycle time.The ability to define “base condition” for the process based on the learning plan results; examples include process centerlines and control variables. Provide process requirements and identification of process-critical equipment parameters to automation designers and manufacturing operationsMetrology understanding including fixturing, lighting, repeatability, reproducibility and equipment used in precision metrology is requiredHands on knowledge and use of metrological devices, calipers, micrometers, shadow graphs, depth gauges etc. is requiredRequires expert skills in Design of Experiments (DOE), Gauge R&R, TMV, Statistical Process Control and Capability and Targeting StatisticsMedical device or regulated industry experience is a plus. GAMP5 knowledge is a plus

Preferred

Minimum of 8 years of automation design, process development incorporating discrete component assembly and joining technologiesStatics, DOE, Gauge R&R, TMV experience bringing pieces of kit to life for discrete component assembly, preferably on class II or III medical devicesDeep knowledge of statistical techniques, Gauge R&R and DOE methods

Other

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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