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Medical Product Development Engineer

Company: Perma Pure LLC
Location: Lakewood
Posted on: November 12, 2019

Job Description:

PERMA PURE MEDICAL PRODUCT DEVELOPMENT ENGINEER THE OPPORTUNITY:Our team is seeking a high-performing product development engineer with a background in medical device design, who is ready to launch products that will transform lives. The ideal candidate has experience with cross-functional teams and has developed medical devices from concept through regulatory clearance. Hours for the position: 8:30 am to 5:00 pm RESPONSIBILITIES:Develop New Medical Products-- Develop and define product and customer requirements for FDA regulated medical devices-- Lead project activities through the management of budgets, resources, timelines, and deliverables-- Lead product and process risk assessments-- Analyze test data, interpret results and formulate conclusions-- Oversee and perform testing and inspection of prototypes and pre-production products-- Investigate, evaluate and select product materials-- Prepare detailed component and assembly drawings-- Lead design reviews-- Lead test method development and have strong knowledge of measurement system analysis (e.g., calibration, accuracy, gage R&R, etc.)-- Assist with 510(k) submissionsGenerate Strong Design History Files (DHF)-- Write and execute protocols for design verification and validation-- Prepare documentation to support regulatory submissionsSupport Our Existing Product Portfolio-- Lead investigation of device failures to determine root cause and corrective action-- Lead process development activities, write work instructions, and develop in-process inspection procedures-- Maintain DHF and ensure documents are complete, accurate, and current-- Communicate effectively with customers and vendors in a technical capacity EXPERIENCE, SKILLS, AND EDUCATION REQUIREMENTS:-- Bachelor's degree in Mechanical or Biomedical Engineering is required-- Minimum 5 years of medical device product design and development experience. Respiratory equipment experience is a major plus.-- Demonstrated ability to bring products from concept to market-- Familiarity with FDA QSR CFR 21 Part 820, ISO 13485 medical device regulations-- Proficiency with risk management per ISO 14971-- Experience with precision manufacturing and injection molding-- Flexibility, persistence, resourcefulness, plus a drive to succeed-- Strong verbal and written communication skills with ability to effectively interact at multiple levels within the organization-- Ability to travel approximately 10% THE PERSON:-- You are flexible, persistent, and resourceful.-- You have a natural drive to succeed.-- You are curious, challenge the status quo and anticipate the future.-- You are an analytical problem-solver, seeking to create win-win solutions.-- You are a strong business partner with good communication skills.-- You are passionate and uncompromising about improving care for patients-- You have a sense of humor.-- You are optimistic, but realistic and pragmatic.-- You like to drive improvement and leave things better than when you started.-- You can empathize with our customers, business partners, and team members.

Keywords: Perma Pure LLC, New York , Medical Product Development Engineer, Healthcare , Lakewood, New York

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