IntePros · 6 hours ago
Project Engineer
Audubon, PA
Full-time
Onsite
Mid, Senior Level
3+ years expIntePros is currently seeking a Project Engineer to join one of their growing Medical Device clients. The Project Engineer will oversee all engineering functions of product lines, managing projects from concept through to product introduction while ensuring compliance with regulatory standards.
ConsultingHuman ResourcesInformation TechnologyStaffing Agency
Responsibilities
Obtains market feedback from surgeons and other customers to determine functional and design specifications for new product development
Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project
Manages all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with client quality system and other applicable regulatory bodies
Designs and develops instruments and implants using Pro/E and SolidWorks software
Partners with in-house prototype shop and outside vendors for rapid prototyping and evaluation
Performs design verification and validation activities to ensure designs meet specifications
Collaborates with marketing and product managers to develop forecasts and market plans
Assists in the writing of regulatory applications to the FDA and other regulatory bodies
Partners with the operations department to setup manufacturing and/or purchasing as appropriate for each project
Participates in product introductions through sales training, customer calls/visits, etc
Maintains diligent post introduction monitoring to address and customer requests for changes
Researches industry and direct competitors on an ongoing basis to ensure that client has cutting edge technology in all markets entered
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures 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
Represents 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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions
Qualification
Required
3-7 years experience in mechanical design engineering; Medical device experience strongly preferred
Bachelor's Degree in Mechanical Engineering, Bioengineering, Biomedical Engineering or a similar degree
Proficiency in Pro/E and/or SolidWorks software for design and drafting
Well organized, detail oriented, and team player capable of working in a deadline driven environment
Experience in preparing reports and managing project budgets
Strong knowledge of Microsoft Office
Ability to attend surgeries and/or labs
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