Medical Device Development Engineer - Regulatory

Medical Device Development Engineer Regulatory

Lynntech is seeking an experienced engineer with a background in new electromechanical medical device development to help build our capability to transition technologies and regulated devices into the marketplace. The Engineer will be involved in the following activities as part of a team of technical and regulatory experts:

• Defining indications for use and intended use
• Capturing user needs and developing design inputs
• Leading risk analyses and risk evaluations in accordance with ISO 14971
• Developing Safety Assurance Cases in accordance with FDA guidance
• Facilitating device design documentation and development processes in accordance with ISO 13485
• Reviewing draft test protocols
• Supporting regulatory strategy development for new devices
• Identifying potential predicate devices and reference devices
• Preparing design documentation in support of presubmission meetings with the FDA and other stakeholder meetings
• Supporting creation and maintenance of Design History File documentation

This position requires both technical expertise and familiarity with regulated medical device documentation and activities and plays a key role in facilitating effective communication of information between technical teams and regulatory affairs teams. The ideal candidate will be able to help technical teams assess their designs from a regulatory and risk management perspective as well as help regulatory personnel understand and frame the technical aspects of the design in a regulatory context.

Qualifications

Minimum qualifications include Master of Engineering or Master of Science in Biomedical Engineering Mechanical Engineering or related engineering disciplines or bachelors degree with at least 2 years of relevant work experience as well as the following demonstrated strengths:

• Phase II/III medical device development experience
• Class II medical device development experience
• Experience working for an established medical device manufacturer
• Experience working with straightforward regulatory pathways and FDA clearance (510(k))
• Familiarity with fluid mechanics thermal management material selection machine design controls and manufacturing
• Proven skills in development of medical devices contributing to requirements definition; risk analysis and evaluation; and prototype design fabrication assembly and testing as a supporting member of a team
• Able to simultaneously consider functionality performance and risk while evaluating designs
• Creating maintaining and revising design documentation within a Quality System (ISO 13485)

Preferred qualifications

The ideal candidate will have a Master of Engineering or Master of Science degree in Biomedical Engineering Mechanical Engineering or related engineering disciplines with 3 or more years of experience or bachelors degree with 5 or more years of relevant work experience as well as the following qualities and experiences:

• Full medical product lifecycle experience from conceptualization through manufacturing sustainment and postmarket monitoring
• Experience in a medical device startup or small business setting with new product development
• Developing devices with challenging regulatory requirements and nuanced regulatory pathways
• Developing disposable/singleuse devices or components and associated durable systems
• Proven leadership skills in developing medical devices leading requirements definition leading risk analysis and evaluation and interfacing directly with regulatory affairs personnel and the FDA
• Training new personnel on following design controls within a Quality System (ISO 13485)
• Familiar with standardized testing (g. IEC test standards MILSTD810)
• Experience with Verification and Validation testing
• Developing and clearing disposable/singleuse devices or components and associated durable equipment
• Leading Design Failure Mode and Effect Analyses (DFMEA)

ABOUT LYNNTECH

Lynntechs mission is to solve real problems in defense aerospace medical and energy markets by developing and commercializing innovative worldclass technologies and products. To accomplish this mission we need team members who are passionate about creating the latest in technology solutions and who are driven to learn and grow.

Lynntech is built on a culture of collaboration you will play an integral role within closeknit groups working daily right alongside other talented engineers scientists and researchers. Throughout your career you will have the opportunity to mature groundbreaking technologies into commercially viable solutions.

Longterm growth opportunities abound in Lynntechs engineering career path where you determine your own ceiling according to your passion proficiency and ability to add value to the engineering team and the organization.

Some of the incredible variety of technology areas that Lynntechs engineers are involved in are:

Medical Devices Air platforms Space platforms Materials and Chemistry Biology and Life Science Human Systems Intelligent Systems Electronics Sensors Weapons Modeling Diagnostics Energy and Power

Interested candidates are encouraged to apply online at .

Lynntech is an EEO Employer.