Are you looking for an opportunity to make a difference? At Mesa Labs we’re passionate about protecting the vulnerable by enabling scientific breakthroughs, ensuring product integrity, increasing patient and worker safety, and improving quality of life around the world.

The Senior Manufacturing Engineer that supports our Agena Biosciences business has responsibility for aiding in the design, development, troubleshooting, and optimization of manufacturing and supporting processes. Position organizes and supports engineering activities and transfer from R&D to manufacturing.

Key Job Responsibilities:

• Provide support for the production of Agena products.
• Develop and document the manufacturing processes. Create product documentation including drawings, BOMs, and specifications.
• Completes change order packages and drives cross-functional approval of the change orders.
• Participates in the resolution of Non-Conformance Reports (NCR) and Corrective Action Preventive Action (CAPA) activities.
• Gather and document input from internal and external sources for the design of components, subassemblies, and manufacturing equipment.
• Designs mechanical/machined test fixtures and assembly jigs.
• Actively participates in pre- and post-production troubleshooting of manufacturing problems.
• Interacts closely with R&D, Manufacturing, Materials , and QA/QC departments in new product introduction/commercialization efforts and technical troubleshooting projects
• Provides direction to lower level Engineers and Manufacturing associates
• Leads outsourcing efforts for equipment design, manufacturing process improvements, contractor/vendor selection and management, etc.
• Understands design for manufacturing in a GMP environment.
• Determines parts and tools needed in order to achieve manufacturing goals according to product specifications. Makes schematics, diagrams, and assembly flow charts.
• Identifies and evaluates areas for process improvements.
• Trains assembly personnel on subassemblies, final assemblies, and test instructions.
• Confers with vendors to determine and meet product specifications.

Qualifications/Education:

• Min of 5+ years of experience in Electromechanical Hardware Engineering environment, medical device or lab tools field preferred, IVD experience a plus
• Bachelor’s degree in a scientific or engineering discipline.
• 5+ years of experience with 3D CAD programs such as Solidworks, AutoCAD, ProE.
• 3+ years of experience working with an electronic documentation and configuration management system such as MasterControl.
• 3+ years of experience working with an material resource planning (MRP) system such as SAP.
• Working knowledge of regulated design controls e.g. ISO 13485, cGMP is preferred.
• Experience in lean manufacturing and/or Six Sigma is preferred
• Previous experience with mass spectrometry (such as MALDI-TOF), a plus

Compensation/Benefits:

The company offers a comprehensive benefits package and compensation for this position. The package includes base salary, bonus, medical/dental/vision insurance, 401k/Match.

Mesa Labs is an Equal Employment Opportunity Employer.

Mesa Labs prohibits unlawful discrimination and harassment against applicants or employees based on age, race, sex, color, religion, creed, national origin or ancestry, disability, military status, sexual orientation, or any other status protected by applicable state or local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)