Senior Mechanical Engineer

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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 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 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 Masters 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:

• You have experience with quality control processes and specification creation

• You have experience with metrology techniques (CT scan CMM OMM 2/3D measurement systems)

• You have strong communication skills including the ability to communicate with all levels within the organization; you are hands-on self-directed organized conscientious.

• You have strong problem-solving judgment and decision-making skills; you have the ability to think and work both tactically and strategically to meet financial and operational needs for GenMarks business

• You have strong time management and organizational skills in a dynamic continually changing environment; you have the 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.

• You have the ability to work effectively exhibit a professional manner and establish constructive working relationships.

• You have excellent written and verbal communication skills and technical documentation

This position is based onsite in Carlsbad CA. This is not a hybrid position.
Relocation benefits are not offered for this job posting.

The expected salary range for this position based in Carlsbad CA is $96000 - $178600. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.
Benefits

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals blood borne pathogens and automated equipment.

While performing the job duties the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision distance vision color vision and ability to adjust focus.

Who we are

GenMark is now a proud member of the Roche Group more than 100000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare Roche Diagnostics offers a broad portfolio of products tools and services that help in the prevention diagnosis and management of diseases like HPV HIV hepatitis and diabetes as well as other medical conditions such as fertility and blood coagulation. With the addition of GenMark to the Roche Group syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMarks ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories while supporting hospital systems to deliver patient-centered value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care reduce costs and increase lab efficiency. GenMark is headquartered in Carlsbad California.

GenMark is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.