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BD (Tissuemed Ltd) · 1 month ago

Staff Engineer - Product & Process Design

Covington, GA

Full-time

Hybrid

Lead/Staff

8+ years exp

BD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Staff Engineer - Product & Process Design will lead product and process design for medical device projects, ensuring manufacturability and quality while collaborating with cross-functional teams.

Health CareHospitalMedicalMedical Device

Responsibilities

Define manufacturing technology strategy for new products, support product design by manufacturability analysis of the devices and their packaging and ensure a successful transfer to the production floor

Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE

Responsible for working with R&D across UCC on the design and development of current and new products. Perform DFA (Design For Assembly) and DFSS (Design For Six Sigma) analysis and establish assembly requirements and implement process controls to ensure product quality and consistency

Guide in design for manufacturability & assembly principles

Define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for manufacture & assembly (DFMA) analysis and enable successful industrialization (internal or external) and transfer to the factories

Ensure the assembly process is understood well to minimize risk. Develop and implement assembly risk mitigation plans

Ensure execution of DFMA efforts will lead to achieving COGS/GP targets in business case

Support the development of DFMA standards and best practices for the Product Manufacturability and Assembly Design GIE team

Collect the opportunities for existing manufacturing processes and identify areas for improvement

Design new manufacturing processes that are efficient, within the targeted CapEx & COGS, and scalable

Suggest alternative design iterations, exploring various form factors, materials, functional solutions to address user needs and manufacturing constraints

Support process validations to ensure compliance with regulatory requirements

Collaborate multi-functionally, especially with R&D and manufacturing specialists to ensure the design aligns with product requirements, and product designs are optimized for manufacturability, assembly, and overall performance

SME in DFMA, engineering, and process for assembly

Review and revise detailed CAD models of product designs, ensuring accuracy/alignment to specifications, standards and manufacturing requirements

Participate in design verification/testing activities

Present sophisticated data in a clear and concise manner to all levels of the organization

Align with all local, state, federal, and BD safety laws, policies, and procedures

Align with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles

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 (DFM/DFx)

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

Coordination and support of all new vendor equipment, tooling, molds, etc

Support development of all products and process documentation

Support in-process test and/or inspection procedure development

Planning, ordering and management of component inventory

Performing process characterization of all new operations and processes

Developing, implementing, analyzing, and writing reports for validation protocols

Developing new product cost estimates

Support preparation of capital equipment requisitions (CB2)

Evaluation and recommendation of new materials

Qualification

DFMAAdvanced ManufacturingProcess ValidationMechanical DesignSolidWorksStatistical SoftwareGMP RegulationsProject ManagementRisk AnalysisGD&TData AnalysisInterpersonal Skills

Required

BS degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent field and 10 years experience OR

MBA or MS in Engineering and 8 years experience

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

Digitalization and automation experience / exposure required

Sound capability to understand concepts and approaches in facilitating strong leadership expected

Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation

Intermediate/Advanced knowledge of design and simulation software's such as the following: SolidWorks, AutoCAD, ProModel, FlexSim

Able to act in multicultural environment and worldwide matrix organizations

Ability to build and implement project plans

Basic tooling, design and drafting knowledge

Ability to analyze data, interpret results, and write reports. Proficient in statistical software

Excellent technical skills including project management, organization, planning, and capital budgets

Excellent Interpersonal Skills - able to express ideas and collaborate optimally 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

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

Ability to interpret, edit and correct part drawings

Understanding of GD&T

Risk analysis / FMEA

Understanding of project management and budgeting