Wearable Medical Device Product Engineer

lifelenstechnologies; Ivyland (PA); On-site; USD 90,000 - 130,000; 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. in Ivyland, PA is seeking a Product Development Engineer to advance electro-chemical medical devices through design controls, verification and validation, and design for manufacturability.

You will collaborate with Manufacturing, QA, Regulatory, and other teams, generate prototypes, perform evaluations, and document design outputs, with emphasis on risk management and compliance with CFR820, ISO standards.

Qualifications

• Bachelor’s degree in engineering or related discipline; advanced degree preferred.
• Minimum 3 years in medical device product development with Design Controls.
• Experience with Class II or III devices and regulatory clearance.
• Experience with electro-mechanical devices and software/firmware preferred.
• Prototyping, DOE, and material characterization experience.
• Knowledge of CFR820, ISO 13485, ISO 14971, IEC 60601, GMP.

Responsibilities

• Generate product concepts/prototypes/designs to meet customer needs.
• Produce design prototypes and conduct performance evaluations to drive design selection and design freeze.
• Support risk management activities such as hazard analysis, dFMEA, pFMEA, etc.
• Collaborate with cross-functional teams (Mfg., QA, RA, etc) to optimize overall design solutions.
• Define and document design output documentation including specifications and drawings.
• Develop and execute design verification and design validation testing strategies.
• Write testing protocols and reports in support of design verification and design validation.
• Communicate relevant information regarding project status, design details, and deliverable content to peer collaborators and management stakeholders.
• Provide technical support to cross-functional team members including technical review of marketing collateral, providing product information for regulatory submissions, etc.
• Other tasks as assigned

Skills

Medical device development

Design Controls

Stage-gate development

DOE

Prototyping

3D printing

Material characterization

Engineering specifications

IQ/OQ/PQ

Regulatory standards

Education

Bachelor’s degree in engineering

Advanced degree preferred

Job description

LifeLens Technologies, Inc. in Ivyland, PA is seeking a Product Development Engineer to advance electro-chemical medical devices through design controls, verification and validation, and design for manufacturability.

You will collaborate with Manufacturing, QA, Regulatory, and other teams, generate prototypes, perform evaluations, and document design outputs, with emphasis on risk management and compliance with CFR820, ISO standards.