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
Location: Warsaw, IN 46580
Duration: 7 Months
Job Type: Temporary Assignment
Work Type: Remote
Job Description:
- Responsible for the post market activities of existing Design History Files for Medical Devices under the direction of a project leader or manager.
- Previous system experience with Vault is preferred. Excellent communication, teamwork, and organizational skills are essential. Candidates must be self-starters and self-motivators.
Principal Duties and Responsibilities:
- Author and Review existing Design History Files, identify scope, and mark gaps where necessary documents are missing
- Utilize Vault Systems to manage Document workflow
- Generate or analyze and update existing risk documentation (DFMEA or risk tables)
- Coordinate, prepare, and conduct design reviews with cross-functional teams
- Perform functional relationship analyses (FRA) and tolerance stack-ups
- Generate comprehensive protocols to test/analyze the product for design verification and design validation (V&V)
- Update prints and other design and manufacturing elements
Required Skills:
Expected Areas of Competence:
- Familiarity with Vault Systems
- Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
- Strong Background in DHF documentation authoring and executing for Medical Devices
- Ability to effectively work within a team to expedite completion of critical project tasks with cross functional groups including Regulatory and Quality
- Establishing a process method which meets performance and quality requirements
- Ability to give clear and concise oral presentations
- Technical writing
- Microsoft Office Suite
Education Requirements:
- B.S. degree from an ABET accredited school (or global equivalent) in Biomedical, Mechanical, or Materials engineering, or equivalent.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN (Remote) |
| Industry | Computer/IT Services |
| Salary | $42 |
| 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
- Analysis Skillsunmatched
- Biomedicineunmatched
- Career Developmentunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Design Verificationunmatched
- Diversityunmatched
- Documentationunmatched
- Functional Analysisunmatched
- Geometric Dimensioning and Tolerancingunmatched
- Manufacturingunmatched
- Materials Engineeringunmatched
- Medical Equipmentunmatched
- Medical Recordsunmatched
- Microsoft Officeunmatched
- Organizational Skillsunmatched
- Orthopedicsunmatched
- Process Developmentunmatched
- Product Designunmatched
- Regulationsunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Testingunmatched
- Validation Testingunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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