Innovative Medical Device Product Engineer

LifeLens Technologies, LLC.; Northern (KY); Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

Health Insurance

Dental & Vision Insurance

Paid Time Off

401(k)

Stock option incentive plan

FSA & dependent care

Job summary

LifeLens Technologies, Inc is seeking a Product Development Engineer to advance electro-chemical medical devices for wearable health applications. You will drive concepts through verification/validation, design outputs, and manufacturability, collaborating with cross-functional teams to meet customer needs and regulatory requirements.

The role emphasizes risk management, documentation, and communication of technical details and project status to stakeholders.

Qualifications

• Minimum 3 years of medical device product development experience with Design Controls and stage-gate processes for Class II or III devices.
• Experience bringing products from concept through regulatory clearance to market.
• Experience with electro-mechanical devices, including software/firmware, is strongly preferred.

Responsibilities

• Generate product concepts and prototypes to meet customer needs.
• Develop and execute design verification and validation testing strategies.
• Create and document design outputs, specifications, and drawings.
• Support risk analyses (hazard analysis, dFMEA, pfMEA).
• Collaborate with Mfg., QA, RA, and other teams to optimize designs.
• Write/testing protocols and reports for verification/validation.
• Communicate project status and deliverables to stakeholders.
• Assist with regulatory submissions and product information for compliance.

Skills

Medical device dev

Design Controls

Stage-gate

DOE techniques

Prototyping

3D printing

Mechanical testing

Material characterization

Regulatory submissions

Cross-functional teamwork

Education

Bachelor's degree in engineering

Job description

LifeLens Technologies, Inc is seeking a Product Development Engineer to advance electro-chemical medical devices for wearable health applications. You will drive concepts through verification/validation, design outputs, and manufacturability, collaborating with cross-functional teams to meet customer needs and regulatory requirements.

The role emphasizes risk management, documentation, and communication of technical details and project status to stakeholders.