IntePros · 12 hours ago
Sr. Project Engineer
Audubon, PA
Full-time
Onsite
Senior Level
5+ years expIntePros is currently looking for a Sr. Project Engineer to join one of their growing Medical Device clients in Audubon, PA. The Sr. Project Engineer will be responsible for all engineering functions of their product lines, including product development from concept through to manufacturing and FDA approvals.
ConsultingHuman ResourcesInformation TechnologyStaffing Agency
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
Qualification
Required
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
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 vision abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
Company data provided by crunchbase