Lead Mechanical Engineer

BioFire Diagnostics; Hazelwood (MO); On-site; USD 120,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

Retirement Plan

Wellness Programs

Job summary

BioFire Diagnostics in Hazelwood, MO is seeking a Lead Mechanical Engineer to manage mechanical design for medical products. Responsibilities include leading R&D activities, designing mechanical components using CAD tools, and ensuring collaboration across various teams.

The ideal candidate will hold a Bachelor's degree in Mechanical or Biomedical Engineering with 7+ years of relevant experience, particularly in design for medical devices. A comprehensive benefits package accompanies a competitive salary range of $120,000 to $175,000.

Qualifications

• 7+ years of professional related experience in complex systems.
• Strong background in mechanical design for precision consumables.
• Experience with design verification and test development.

Responsibilities

• Lead R&D activities for New Product Introduction (NPI).
• Design and develop mechanical components using CAD/PDM tools.
• Collaborate cross-functionally to ensure design intent is met.

Skills

Mechanical design

CAD (SolidWorks)

Data analysis

Project management

Communication

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Master's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Statistical analysis software (JMP, MiniTab)

Job description

Lead Mechanical Engineer

Location: Hazelwood, MO
Department: Mechanical Engineering
Reports To: Associate Director – Mechanical Engineering

Position Summary

This lead engineer works primarily with the mechanical design aspects of consumables and reagents team, representing Systems Development in reagent design – generally under the leadership of a principal engineer or functional manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company.

Primary Duties

1. Lead R&D Activities for New Product Introduction (NPI) for the VITEK Reveal panel and sensor, supporting the full lifecycle from concept through design transfer to manufacturing.

2. Own the mechanical design and development of panel and sensor process assemblies, including any plastic treatment features.

3. Design, model, create drawings, and release mechanical components using CAD/PDM tools (SolidWorks) including application of GD&T (in accordance with ASME Y14.5) and tolerance analysis to ensure robust performance, and adequate interfaces with other components/instruments.

4. Develop and support the validation of the plasma treatment solution including: a. Definition of plasma treatment requirements based on functional, chemical, and biological needs. b. Collaboration with suppliers and process engineers on plastic treatment selection, parameters, and scalability. c. Support of plastic treatment characterization, qualification, and long‑term performance.

5. Drive DFMEA and design reviews, ensuring compliance with internal design controls and regulatory requirements and participate in PFMEA.

6. Support design verification and validation (DVV) activities, including test method definition, fixture design, execution, and data analysis.

7. Collaborate cross‑functionally with R&D, Systems, Manufacturing, Quality, Regulatory, and Supply Chain teams to ensure design intent is met.

8. Support manufacturing readiness, including DFM/DFA activities, tooling design, pilot builds, and yield improvement.

9. Investigate and resolve design- or process‑related issues, including root cause analysis and implementation of corrective actions.

Qualifications

Required Qualifications

• Bachelor's degree required – Mechanical or Biomedical Engineering

• 7+ years of professional related experience in complex systems of hardware, software, biology, materials science, or chemistry

Preferred Qualifications

• Master's degree Preferred – Mechanical or Biomedical Engineering

• Demonstrated understanding of design and manufacturing processes for injection molding, machining, liquid dispensing, welding, design of experiments, and capability analysis

• Strong background in mechanical design for precision consumables, preferably with medical devices, diagnostics, or life sciences instrumentation

• Experience with surface treatments and plasma coating technologies including materials compatibility and performance testing

• Previous working experience supporting product development processes from initial state including manufacturing process and transfer to manufacturing

• Experience with design verification, test development, and statistical data analysis

• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements

• Hands‑on mechanical and electro‑mechanical troubleshooting skills of automated manufacturing equipment

• Experience in process characterization and development, acceptance testing and qualification of automated equipment

• Experience with statistical analysis software (JMP, MiniTab or similar)

• Excellent verbal and written communication skills to present summary data to cross‑functional team

• Project management experience would be a plus

Knowledge, Skills, and Abilities (KSAs)

• Acting with Honor and Being Open — Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.

• Communicating Effectively — Effective Presentation Skills, including the ability to present technical data.

• Dealing with Complex Situations — Demonstrates assertiveness and confidence in the face of a challenge.

• Intellectual Horsepower — Analyze data and make decisions/recommendations, using data to guide decision‑making and provide suggestions for improvement.

• Intellectual Horsepower — Critical thinking, using logic and reason to analyze information and make decisions in the workplace.

• Intellectual Horsepower — Manage and meet competing deadlines, requiring careful prioritization and time management to ensure all tasks are completed on time.

• Functionally Required Knowledge, Skills, and Abilities — Mechanical CAD for 3D Modeling and Drawings (SolidWorks preferred).

• Engineering Drawing Standards (ASME Y14 preferred).

• Theoretical mechanical engineering analysis on prospective designs.

Supervisory Responsibilities

No direct or indirect reports. Makes operational and strategic decisions with little‑to‑no supervisory review.

Working Conditions

Role requires remaining stationary for prolonged periods and working in a typical lab/office setting. Domestic travel: 5%. International travel: 5%. Total travel: 10%.

Compensation and Benefits

The estimated salary range for this role is between $120,000 and $175,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. The compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

• Choice of medical (including prescription), dental, and vision plans with telemedicine options
• Company‑Provided Life and Accidental Death Insurance
• Short and Long‑Term Disability Insurance
• Retirement Plan including a generous non‑discretionary employer contribution and employer match
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leave