Senior Product Engineer

About Us:

CARR Biosystems is a growing business providing critical technology for cutting-edge life science innovations. Our customers are inventing tomorrow's solutions to treat and cure disease, and our centrifuge technology is enabling it. We're part of a $3.3 billion parent company (Barry-Wehmiller) where culture is a priority. Our goal is to have performance and people in harmony - and we believe work should be fun, we should inspire our teammates, and each team member is someone's precious child. We feel it's a unique opportunity to build the future of CARR Biosystems. If this excites you, please read on…

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Job Description:

The Senior Product Engineer at CARR Biosystems is a dynamic individual who drives the design and production launch of life saving bioprocessing products. The incumbent will be responsible for machine and product designs, developing a vendor base to manufacture those designs, validating the designs meet project requirements, and ultimately releasing designs for production. This includes generating solid models and 2D drawings, managing DFM activities with vendors and colleagues, running approved Validation Master Protocols (VMPs), and following Engineering Change Order (ECO) processes. The position demands a highly collaborative and cross-functional approach, leveraging both internal insights and external best practices to innovate and refine designs and manufacturing processes. Adaptive communication is key for this individual to coordinate across various stakeholders, setting clear objectives, and maintaining transparency on project progress, challenges, and solutions.

Responsibilities:

• Develop blank-sheet designs or revise established machines and products based on project scope, cross-functional inputs, and voice of customer (VOC).

• Define technical specifications and requirements for machine and product designs.

• Drive collaboration with third-party vendors in the development and fabrication of equipment and tooling, including semi-automated manufacturing equipment and injection molds and resulting molded components.

• Work collaboratively with cross-functional teams, including quality, supply chain, design engineering, operations, and product management, to facilitate Stage Gate process of assigned NPD projects.

• Exhibit effective communication across all levels of the organization, including with project team members, cross-functional departments, and executive sponsors regarding project status, timelines, budgets, and direction.

• Direct validated process transition to operations and/or sustaining engineering teams, providing clear guidelines for routine production.

• Propose continuous improvement and innovation in machine design, product design, and manufacturing processes while applying best practices to enhance efficiency and product quality.

• Calculate tolerance stack-ups including GD&T, seal compression, and force required to compress seals among other design calculations as needed to support assigned projects.

• Identify and select materials to meet performance requirements including stainless-steel alloys, plastic compounds, and ceramics.

• Size and select machine components such as pumps, valves, filters, hoses as needed while ensuring cleanability in a sterile environment.

• Design machines and products using SolidWorks CAD software.

• Ensure design compliance with appropriate regulatory standards such as BPE, 21CFR, ISO 9001/13485, and cGMP.

• Should be familiar with intermediate FEA for virtual prototyping of designs.

• Become familiar with P&ID designs for CIP/SIP systems.

• Submit and manage vendor quote requests.

• Direct and collaborate on DFM activities with vendors and colleagues.

• Leverage experience with machining, injection molding, plastic laser welding, plastic blow molding, ultrasonic welding, and other manufacturing processes to achieve part quality, reliability, cost targets, and vendor deliverables.

• Direct and support capital expense tooling and equipment initiatives including injection molding tooling and custom automated assembly equipment.

• Leverage experience with additive manufacturing to complete prototyping and fixturing activities.

• Develop and gain approval for IQ, OQ, PQ, protocols per VMP process.

• Conduct Risk Analysis using FMEA and Root Cause tools as needed to drive actions to completion.

• Physically test or coordinate testing of designs to show compliance with project requirements.

• Travel: Up to 10% domestic and/or global travel may be required for this position.

Required Education and Experience:

• Bachelor's degree in Mechanical Engineering, or a related engineering field.

• 10+ years of experience in mechanical design or machine design roles responsible for design development, testing, and production release.

• 10+ years experience doing CAD in Solidworks modeling and drawing with full dimensions and tolerances.

• At least 5 years of experience working in NPD/R&D with injection molded plastic parts.

• Proficiency in equipment and process validation ideally within the biopharmaceutical manufacturing sector.

• Strong knowledge of regulatory compliance and quality assurance ideally within bioprocessing component manufacturing.

• Proven success in production releases/product launches involving diverse project teams and effective team collaboration.

• Excellent communication skills with the ability to articulate complex ideas and strategies to a variety of audiences.

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At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

Company:

CARR Biosystems