Job Description
Our client, a Medical Devices/Healthcare company, is looking for a Development Sr Engineer I for their Warsaw, IN/Hybrid location.
Responsibilities:
Requirements:
Why Should You Apply?Excellent growth and advancement opportunities
Responsibilities:
- Harmonizes design controls and risk management procedures from a new acquisition with the global design controls and risk management processes at Client
- Supports integration activities by authoring remediation protocols and assisting the team reaching the correct decisions on integration strategy.
- May serve as technical lead or project manager for feasibility workstreams and small-scale, lower-complexity projects involving new product development, technology integration, design changes, or manufacturing/sourcing transfers under appropriate supervision.
- Creates and communicates project plans, timelines, budgets, resource needs, technical deliverables, decision criteria, risks, contingency plans, and status updates to stakeholders and leadership.
- Applies understanding of orthopedic infection prevention and treatment practices, clinical workflows, product intended use, and applicable regulations to support review of site documentation to identify any gaps or opportunities for improvement with guidance from technical and cross-functional leaders.
- Plans and coordinates deliverables with cross-functional teams and external partners.
- Develops product and process specifications, identifies critical-to-quality attributes, and supports quality control strategies based on intended use, design requirements, material and biological performance, infection-relevant performance attributes, and user risks.
- Authors, reviews, and obtains cross-functional approval of design control, risk management, regulatory, and evidence-supporting documentation, including materials for regulatory activities associated with the integration.
- This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Requirements:
- Demonstrated strong written and verbal communication skills, with the ability to communicate technical information to cross-functional and global audiences. Specifically, experience writing procedures, protocols, and technical rationales is preferred.
- Microsoft Office Suite software proficiency required.
- Working knowledge and familiarity with the following Medical Device Standards / Regulations: 21 CFR Part 820 QSR (2024), ISO 13485, ISO 14971, MDD, MDR, IEC 62366-1, ISO/IEC 27001, BS EN 62304. Familiarity with drug-device combination products and software as a medical device is preferred.
- Demonstrated working knowledge of statistics applied to engineering studies, including sample size rationale, design of experiments, and hypothesis testing; Minitab experience desired.
- Bachelor's Degree in Engineering and 3 years of relevant experience or equivalent experience.
- Degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Biomedical Engineering, Bioengineering, Materials Science or Materials Engineering, Chemical Engineering, Polymer Engineering, or a related engineering discipline highly preferred.
- 3-5 years of full-time engineering experience in regulated medical device product development highly preferred.
- Experience with orthopedic implants, medical software, biomaterials, antimicrobial technologies, wound management, coatings, or local drug delivery is strongly preferred.
Why Should You Apply?Excellent growth and advancement opportunities
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Management Consulting Services |
| Salary | $30.68–$33.47 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
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