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 Senior Product Development Engineer. This is a full-time, on-site position. The ideal candidate is a self-starter who is collaborative, detailed oriented, and goal driven. You excel at developing concepts, resolving technical issues and providing support in a dynamic environment. You will have the opportunity to work on advanced, cutting-edge technologies designed to revolutionize wearable health care. Your passion and drive will be rewarded with a competitive salary, benefits, and long-term growth opportunities.

As Senior Product Development Engineer, you will be responsible for leading the development of software- driven electro-mechanical medical devices. You will be responsible for leading all phases of device development, in particular, the identification and evaluation of design options, the definition of product/performance specifications, design verification/validation activities, creation of technical data, generation of documentations for Design History File as well as designing for manufacturability are important aspects of this role.

Responsibilities Include:

• Lead development of product concepts/prototypes from initial design to commercial release.
• Assist with user needs collection activities using various methods including medical literature reviews, stakeholder surveys and interviews, key opinion leader (KOL) panel discussions, etc.
• Develop and document design input requirements and user needs.
• Partner with software/firmware development teams and other cross functional partners (Mftr, QA, RA, etc) to optimize overall design solution .
• Produce design prototypes and conduct feasibility performance evaluations to inform design selection and design freeze.
• 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.
• Support risk management activities such as hazard analysis, dFMEA, uFMEA, etc.
• 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 technically reviewing marketing collateral, providing product information for regulatory submissions, etc.

Qualifications:

• Bachelor’s Degree in Engineering or related discipline (e.g. Physical or Life Science) with an advanced degree preferred.
• Minimum 7 years 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 preferred.
• Working knowledge of and experience in applying Design Controls and international standards (e.g. CFR820, ISO 13485, ISO 14971, IEC 60601, GMP, etc.).
• Must be able to collaborate effectively with others and works well within cross-functional teams.
• Must be able to communicate effectively, both verbally and written. Comfortable presenting information to team members and stakeholders.
• Ability to travel 5-10%

Benefits:

• Health Insurance
• Dental & Vision Insurance
• Paid Time Off
• Flextime