Senior Mechanical Engineer

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche / GenMark Diagnostics’ mission is to revolutionize patient care by providing high-value, simple-to-perform, and clinically relevant multiplex molecular diagnostics, specifically targeting infectious disease testing. We aim to improve patient outcomes, enhance laboratory efficiency, and reduce total cost-of-care through rapid, sample-to-answer solutions.  

Roche/Genmark Diagnostics is seeking a Senior Mechanical Engineer (Sr. Engineer) to join our team. In this role, the Sr. Engineer will be responsible for defining the requirements for new tooling and part designs to deliver high quality plastic injection molded products in a timely and cost-efficient manner. In addition, the Senior Engineer will collaborate with procurement, quality assurance, quality control, operations, document control teams on validation and verification for injection molding tools. This is a highly visible role; allowing the Sr. Engineer to make an immediate impact within the team.

The Opportunity:

• You will create, review, and execute engineering change process for consumable components

• You will complete assembly and part drawings as well as other required documentation from design concept to manufacturing transfer; you will work with production teams to transfer verified designs into full production using principles of DFM/DFA

• You will technically manage projects by identifying, planning, & scheduling technical activities for successful completions.

• You will participate or lead in failure analyses, First Article Inspections, and test method development.

• You will transfer troubleshooting knowledge to Operations, Production, and Contract Manufacturers as new problems arise; you will interact with suppliers and contract manufacturers to ensure parts and assemblies can be reliably produced against material specifications.

• You will perform and document feasibility, design, verification, validation, and risk analysis activities under design controls within the new product development process potentially working alongside outsourced partners.

• You will develop test and development strategies and plans of substantial scope and duration that may include coordinating contributors across teams and outsourced partners..

• You will provide engineering and troubleshooting support to assay integration and development teams.

Who You Are:
(Required)

• You have a B.S. in mechanical engineering, chemical engineering, bio-engineering (or equivalent area of study) with 5+ years of industry experience; or a Master’s in mechanical engineering, chemical engineering, bio-engineering (or equivalent area of study) with 3+ years of industry experience; or or Ph. D. level in mechanical engineering, chemical engineering, bio-engineering, (or equivalent area of study) w/ 1+ years of industry experience.

• You have demonstrated experience with the engineering change control process, including technical report documentation, quality document management, and validation and verification activities.

• You have demonstrated experience with CAD (SolidWorks preferred), including drafting to ASME Y14.5 and GD&T standards.

• You have demonstrated experience in the design, DFM, and production of injection molded plastics, including rapid prototyping, prototype molding, and multi-cavity production molds.

• You are highly skilled at developing and sustaining medical or in-vitro diagnostics consumables and instrumentation working within an ISO 13485/GMP compliant environment.

• You have demonstrated experience in root cause analysis techniques for mechanical parts and assemblies; you have experience with plastic assembly techniques such as ultrasonic and laser welding; you have experience with PDM systems, specifically SolidWorks PDM, is desirable.

• You are proficient with root cause analysis, design of experiments, data analysis, and tolerance analysis techniques.

Preferred: