BD · 3 weeks ago
Staff Engineer, Process Development
USA RI - Warwick
Full-time
Onsite
Lead/Staff
8+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovation. The Staff Engineer, Process Development will lead the development of superior products and efficient processes, focusing on technical excellence in product assembly and process development while collaborating with R&D and Operations.
Health CareMedical DeviceTechnical Support
Responsibilities
Define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for assembly (DFA) analysis and enable successful industrialization (internal or external)
Work with the R&D cross functional team on product design and process development for new products
Collaborated with product development engineers on defining manufacturable product specifications
Perform DFM/A (Design for Manufacturability/Assembly) assessments
Establish assembly requirements KPIVs and KPOVs to ensure effective equipment selection as well as informing process validation strategy
Design new assembly processes that are efficient, scalable and within the targeted CapEx & COGs
Present complex data in a clear and concise manner to all levels of the organization
Author characterization reports as required
Handle R&D pilot scale builds to support development activities
Present any risks and develop mitigation plans that relate to new product industrialization
Assemble the opportunities for existing assembly processes and identify areas for improvement and inclusion into future DFA
Provide experience in cross-functional collaboration and leadership skills
Support operations during a production challenge. (quality, supplier, etc.)
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles
Other duties as assigned
Support new product team design activities including:
Provide technical leadership in the concept development of design control documentation
Works both independently and/or collectively to develop project plans and execution of prioritizing and scheduling assignments to meet business goals
Lead technical process reviews
Work with design team to ensure components/assemblies are designed for manufacturability/excellence
Able to plan, coordinate and lead all technical activities associated with commercialization and launch of new products including:
Conceptualization and development of all manufacturing processes and methods
Coordination of all development and manufacturing of new tooling and equipment
Support makes vs buy analysis and identifying new vendors
Support site selection activities
Support development of all products and process documentation
Support in-process test and/or inspection procedure development
Planning, ordering and management of component inventory
Developing new product cost estimates
Support preparation of capital equipment requisitions (CB2)
Evaluation and recommendation of new materials
Qualification
Required
BS degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required
Min 8 years' experience with BS or 5 years' with MS degree
5+ years of experience in advanced manufacturing engineering, product design, and/or technical leadership level in Medical Device or other highly regulated industries. OR 5+ years of professional experience in mechanical design, with a significant and demonstrable focus on applying DFMA principles
Demonstrated experience leading/deploying Advanced Manufacturing initiatives
Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation
Intermediate/Sophisticated knowledge of design and simulation software's such as the following: SolidWorks, AutoCAD
Basic tooling, design and drafting knowledge
Understanding and ability to implement DOEs, process characterizations and validations using standard statistical techniques
Understanding of GMPs and medical device regulations as they apply to manufacturing
Understanding of GD&T, component tolerance stack up and assembly tolerance requirements
Risk analysis / pFMEA
Understanding of project management and budgeting
Ability to build and implement project plans
Ability to analyze data, interpret results, and write reports
Proficient in statistical software: Minitab
Excellent technical skills including project management, organization, planning, and capital budgets
Ability to interpret, edit and correct part drawings
Able to act in multicultural environment and worldwide matrix organizations
Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams
Ability to work with minimal guidance, conceptualize ideas, motivate, and focus individuals and teams and drive projects through completion on time and on budget
Preferred
Experience with both manual and semi-automated production lines preferred
Textile/medical textile processing
Extrusion, knitting, etc
Benefits
Relocation Assistance May Be Available For This Position Subject To Company Policy.
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
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