Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world.
Job Title: Sr. Development Engineer I
Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job description:
Expected Job Duties
- 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.
Skills:
- 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.
Education:
- Minimum Requirements: 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.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $37.15 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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