Product Development Engineer

LifeLens Technologies, Inc.; Warminster Township (Bucks County); 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 from concept through verification and regulatory readiness.

You will collaborate with manufacturing, QA, RA and cross-functional teams, craft design outputs, develop test protocols, and contribute to design history files while ensuring manufacturability.

Qualifications

• 3+ years of experience in medical device product development with Design Controls and stage-gate processes.
• Experience bringing products from concept through regulatory clearance to market.
• Experience with electro-mechanical devices including software/firmware is preferred.
• Proficiency applying DOE and experimental design methods for evaluating changes.
• Experience with prototyping, 3D printing, mechanical testing, and material characterization.
• Define and document engineering specifications and process docs used in manufacturing.
• Working knowledge of Design Controls and standards (e.g., CFR820, ISO 13485, ISO 14971, IEC 60601, GMP).
• Experience in IQ/OQ/PQ for manufacturing equipment and processes.
• Strong communication skills, both verbal and written.

Responsibilities

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

Skills

Medical device product development

Design Controls

Stage-gate development

Prototyping

Regulatory support

DOE

Communication

Education

Bachelor’s degree in engineering or related discipline

Advanced degree preferred

Tools

3D printing

Mechanical testing equipment

IQ/OQ/PQ

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. You are 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