Product Development Engineer

LifeLens Technologies, LLC.; Ivyland (PA); On-site; USD 85,000 - 125,000; 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 seeks a Product Development Engineer to advance electro-chemical, medical devices from concept through verification and regulatory readiness. You will work with cross-functional teams to develop prototypes, write test protocols, and contribute to the Design History File.

The role emphasizes design controls, risk management, and collaboration with manufacturing, QA, and RA.

Qualifications

• Bachelor’s degree in engineering or related discipline; advanced degree preferred.
• 3+ years in medical device product development with Design Controls.
• Experience applying CFR820, ISO 13485, ISO 14971 for devices.

Responsibilities

• Generate product concepts/prototypes to meet customer needs.
• Develop design verification/validation plans and reports.
• Support risk management activities (hazard analysis, dFMEA, PFMEA).
• Collaborate with Mfg, QA, RA to optimize designs.
• Define design outputs including specs and drawings.
• Prepare documentation for Design History File.
• Provide technical support for regulatory submissions.

Skills

Design Controls

Stage-gate development

DOE

Prototyping

3D Printing

Cross-functional

Software/Firmware

Education

Bachelor’s degree in engineering or related discipline

Tools

Regulatory Standards

IQ/OQ/PQ

ISO 13485

IEC 60601

Job description

LifeLens Technologies, Inc is a medical device developer located in Ivyland, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.

We are seeking to hire a Product Development Engineer. In this role, you will have the opportunity to work on cutting-edge technologies designed to revolutionize wearable health care. You have a collaborative mindset and a passion for developing new technology. Youare detail-oriented and goal-driven. You are a capable problem solver with excellent organizational skills and superior verbal and written communication skills.

Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.

This is a full-time, on-site position.

Summary

The Product Development Engineer participates in the development of electro-chemical, medical devices. They play an important role in all phases of device development and designing for manufacturability. This role includes the identification and evaluation of design options, the definition of product/performance specifications, design verification/validation activities, the creation of technical data; and the generation of documentation for the product’s Design History File.

Essential Functions

• 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

Competencies

• Required - minimum 3 years of experience in medical device product development utilizing Design Controls and stage-gate development processes for Class II or III devices.
• Demonstrated ability to bring products from concept through regulatory clearance and to market.
• Experience in electro-mechanical devices, including software/firmware, is strongly preferred.
• Demonstrated ability in applying DOE and other experimental techniques when evaluating new or changes to existing products and processes, and materials/compositions
• Experience in prototyping, 3D printing, mechanical testing, and material characterization.
• Define and document engineering specifications and process documentation used in the manufacturing process.
• Working knowledge of and experience in applying Design Controls and international standards (e.g. CFR820, ISO 13485, ISO 14971, IEC 60601, GMP, etc.).
• Experience in installation qualifications of manufacturing equipment and associated processes (IQ/OQ/PQ).Must be able to communicate effectively, both verbally and written. Comfortable presenting information to team members and stakeholders.

Required Education

• Bachelor’s degree in engineering or related discipline (e.g. Physical or Life Science) with an advanced degree preferred.

Benefits:

• Health Insurance
• Dental & Vision Insurance
• Paid Time Off
• 401(k)
• Stock option incentive plan
• FSA & dependent care