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: Development Engineer I
Work Location: Warsaw, IN
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Duties and Responsibilities:
- With oversight from supervisor and mentorship by senior peers: Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards
- Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage
- Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards
- Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features
- Prepares and reviews information for invention disclosures and patents
- Initiates, provides instruction for and coordinates with support from Client cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation
- Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection
- Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated
- Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with Client procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
- Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with Client procedures and global regulatory requirements
- Supports Client Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities
Skills:
- You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further Client's mission and grow Client's market leadership position.
Education:
- Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $46.44 |
| 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
- ABET (Accreditation Board for Engineering and Technology)unmatched
- Aeronautical Engineeringunmatched
- Aerospace Engineeringunmatched
- Bioengineeringunmatched
- Biomedical Engineeringunmatched
- Career Developmentunmatched
- Cross-Functionalunmatched
- Customer Support/Serviceunmatched
- Design Documentunmatched
- Design Verificationunmatched
- Diversityunmatched
- Documentationunmatched
- Industry Standardsunmatched
- Invention Disclosuresunmatched
- Invention Reviewsunmatched
- Leadershipunmatched
- Manufacturingunmatched
- Manufacturing Designunmatched
- Market Shareunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Mentoringunmatched
- Needs Assessmentunmatched
- Orthopedic Surgeryunmatched
- Orthopedicsunmatched
- Patentsunmatched
- Process Capabilityunmatched
- Process Validationunmatched
- Product Designunmatched
- Product Developmentunmatched
- Product Testingunmatched
- Production Specificationsunmatched
- Prototypingunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Requirements Managementunmatched
- Resolve Customer Issuesunmatched
- Risk Managementunmatched
- Training/Teachingunmatched
- Validation Testingunmatched
- Workforce Managementunmatched
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