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Sr. Project Engineer
Accepting applicationsIntePros · Audubon, PA
Full-Time Senior aiateddrganrf
Posted
4d ago
Category
Test
Experience
Senior
Country
United States
IntePros is currently looking for a Sr. Project Engineer to join one of our growing Medical Device clients in Audubon, PA. The Sr. Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work closely with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions.
Sr. Project Engineer Responsibilities
Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
Create and maintain project plans and FDA complaint Design history Files (DHF) for each project
Manage of all aspects of project to ensure timely completion of tasks while remaining in full compliance with client quality system and other applicable regulatory bodies
Design and develop instruments and implants using Pro/E software
Partner with in-house prototype shop and outside vendors for rapid prototyping and evaluation
Perform design verification and validation activities to ensure designs meet specifications
Partner with marketing and product managers to develop forecasts and market plans
Assist in the writing of regulatory applications to the FDA and other regulatory bodies.
Collaborate with the operations department to setup manufacturing and/or purchasing as appropriate for each project
Participate in product introductions through sales training, customer calls/visits, etc.
Maintain diligent post introduction monitoring to address and customer requests for changes
Research market and competition on an ongoing basis to ensure that client has cutting edge technology in all markets entered
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of client
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Sr. Project Engineer Qualifications
Minimum five years of mechanical design engineering experience, preferably in the medical device field
Bachelor's degree in Mechanical Engineering or similar area of study
Proficiency in Pro/E software for design and drafting required
Proven leader of people with strong self-starting skills
Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
Well organized, detail oriented and team player capable of working in a deadline dictated environment
Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
Proficient in preparation of reports and budgets
Proficient in Microsoft Office
Physical Demands
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
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Sr. Project Engineer Responsibilities
Obtain market feedback from spine surgeons and other customers to determine functional and design specifications for new product development
Create and maintain project plans and FDA complaint Design history Files (DHF) for each project
Manage of all aspects of project to ensure timely completion of tasks while remaining in full compliance with client quality system and other applicable regulatory bodies
Design and develop instruments and implants using Pro/E software
Partner with in-house prototype shop and outside vendors for rapid prototyping and evaluation
Perform design verification and validation activities to ensure designs meet specifications
Partner with marketing and product managers to develop forecasts and market plans
Assist in the writing of regulatory applications to the FDA and other regulatory bodies.
Collaborate with the operations department to setup manufacturing and/or purchasing as appropriate for each project
Participate in product introductions through sales training, customer calls/visits, etc.
Maintain diligent post introduction monitoring to address and customer requests for changes
Research market and competition on an ongoing basis to ensure that client has cutting edge technology in all markets entered
Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of client
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Sr. Project Engineer Qualifications
Minimum five years of mechanical design engineering experience, preferably in the medical device field
Bachelor's degree in Mechanical Engineering or similar area of study
Proficiency in Pro/E software for design and drafting required
Proven leader of people with strong self-starting skills
Ability to work in fast paced environment; Multi-tasking abilities required for successful job completion
Well organized, detail oriented and team player capable of working in a deadline dictated environment
Ability to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers
Proficient in preparation of reports and budgets
Proficient in Microsoft Office
Physical Demands
The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Show more Show less