Senior Mechanical Engineer

Roche•Carlsbad, NM

22h•Onsite

About 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.

Requirements

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
Demonstrated experience with the engineering change control process, including technical report documentation, quality document management, and validation and verification activities
Demonstrated experience with CAD (SolidWorks preferred), including drafting to ASME Y14.5 and GD&T standards
Demonstrated experience in the design, DFM, and production of injection molded plastics, including rapid prototyping, prototype molding, and multi-cavity production molds
Highly skilled at developing and sustaining medical or in-vitro diagnostics consumables and instrumentation working within an ISO 13485/GMP compliant environment
Demonstrated experience in root cause analysis techniques for mechanical parts and assemblies
Experience with plastic assembly techniques such as ultrasonic and laser welding
Proficient with root cause analysis, design of experiments, data analysis, and tolerance analysis techniques

Nice To Haves

Experience with PDM systems, specifically SolidWorks PDM, is desirable
Experience with quality control processes and specification creation
Experience with metrology techniques (CT scan, CMM, OMM, 2/3D measurement systems)
Strong communication skills including the ability to communicate with all levels within the organization
Hands-on, self-directed, organized, conscientious
Strong problem-solving, judgment and decision-making skills
Ability to think and work both tactically and strategically to meet financial and operational needs for GenMark’s business
Strong time management and organizational skills in a dynamic, continually changing environment
Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals
Ability to work effectively, exhibit a professional manner and establish constructive working relationships
Excellent written and verbal communication skills and technical documentation

Responsibilities

Create, review, and execute engineering change process for consumable components
Complete assembly and part drawings as well as other required documentation from design concept to manufacturing transfer
Work with production teams to transfer verified designs into full production using principles of DFM/DFA
Technically manage projects by identifying, planning, & scheduling technical activities for successful completions
Participate or lead in failure analyses, First Article Inspections, and test method development
Transfer troubleshooting knowledge to Operations, Production, and Contract Manufacturers as new problems arise
Interact with suppliers and contract manufacturers to ensure parts and assemblies can be reliably produced against material specifications
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
Develop test and development strategies and plans of substantial scope and duration that may include coordinating contributors across teams and outsourced partners
Provide engineering and troubleshooting support to assay integration and development teams