Engineer V, Consumables

POSITION SUMMARY:

The Consumables Engineer V is a hands-on technical lead role and serves as one of the foremost subject matter experts for the organization in regard to best practices in the design and development of high-volume, injection molded components and assemblies used is bio-tech and diagnostic products. Design work will include “clean sheet” design of new plastic consumables, including the design of single and mult-shot components, design for manufacturing and assembly, design of test fixates and development of test methods to ensure product performance.

In addition to detailed design work, this position is responsible for setting goals and objectives for the development of new product consumables and injection molded plastic components, as well as the support of existing components for the biodefense, clinical and life-science markets. The incumbent will also provide general oversight to team members performing the planning, documentation, prototyping and testing of designs.

DUTIES AND RESPONSIBILITIES:

• Principal designer and team leader for mechanical design of new plastic components

o Lead cross-functional teams to support the design and development of MSD plastic components

o Lead the mechanical design, prototyping, testing, and troubleshooting of new injection molded components

• Contribute to the development of overall strategies/goals and objectives of the project by:

o Participating in project planning activities

o Presenting designs, engineering issues, and solutions to senior engineering and company management as required

o Ensure that the goals/strategies are clearly defined and cascaded down to team members.

• Participate and provide overall guidance in all phases of product development including feasibility, requirements and specification development, planning, design, verification, validation, transfer to manufacturing, and lifecycle support in conformance with ISO and FDA cGMP processes as applicable

• Coordinate with various groups to ensure product completion:

o Transfer to manufacturing and provide ongoing lifecycle support

o Oversee the development of written assembly and test procedures for new designs

o Provide oversight to the planning, design, build and testing of manufacturing test fixtures to support production of new consumable products

• Supervise the work of others and mentor junior level engineers

• Interact with outside vendors and MSD’s supplier quality department to source and qualify parts

• Specific duties may vary depending upon department requirements

EXPERIENCE AND QUALIFICATIONS:

• Bachelor’s degree in Mechanical Engineering.

o Advanced degree in Mechanical Engineering preferred

• Twenty years of industry relevant experience preferred

• Experience in the design and development of injection molded components and assemblies used in the commercial or laboratory space and manufactured at scale

• A portfolio review of relevant work from feasibility to scale manufacturing

• Experience in an ISO or cGMP environment required

• Demonstrated CAD skills and experience are required

• A minimum of one year of supervisory experience required.

• Experience with single and multi-shot part design is a must

• Medical or scientific plastic design experience preferred

• Experience with multicavity, high-volume production (>1M/year) preferred

• Experience with designing for scale manufacturing strongly preferred

• Experience with the design and development of novel products used to enable biological assays is a plus.

KNOWLEDGE, SKILLS AND ABILITIES:

• Must be able to conceive, design, and realize new hardware designs through concept development and consensus building.

• Advanced understanding of injection mold tooling fabrication techniques required

• Expert knowledge of tooling validation process

• Strong engineering fundamentals and analytical background

o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion

• Excellent oral, written, and interpersonal communication skills

o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data

• Demonstrated propensity to be creative, collaborative, proactive, and self-motivated in the execution and completion of assigned accountabilities.

• Ability to lead, train, guide others to understand and accomplish tasks/duties/responsibilities.

• Proficiency and knowledge of GD&T tolerancing practices required

• Proficiency with Solidworks, I-DEAS, Pro/Engineer, or other comparable advanced CAD software.

• Proficiency in MS Office suite

• Demonstrated ability to develop, integrate and validate systems, in a GMP, ISO or other regulated production environment