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 - 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Remote
Job Summary:
Duties:
- This role primarily supports remediation of existing product Design History Files (DHF) and Risk Management Files (RMF), closing documentation gaps and strengthening traceability.
- It also provides engineering support for product changes, design controls and quality activities.
Principal Duties and Responsibilities:
- Applies product, clinical, regulatory and standards knowledge to legacy DHF/RMF remediation.
- Reviews available user needs and intended-use documentation for completeness and consistency.
- Checks traceability among user needs, design inputs, outputs and supporting verification/validation evidence; documents gaps for remediation.
- Reviews design rationale and supporting records; updates documentation to address identified gaps.
- Identifies and coordinates retrieval of objective evidence needed to complete DHF/RMF records.
- Coordinates with cross-functional teams to locate and assess design verification, validation and process-validation evidence.
- Reviews production specifications and inspection records for completeness and consistency with design documentation.
- Links critical-to-quality features and inspection evidence to applicable design requirements and risks.
- Reviews design verification, validation and risk-control evidence against requirements and applicable procedures.
- Partners with Quality, Regulatory, Manufacturing and Sourcing to resolve documentation gaps and obtain approvals.
- Assesses test-method documentation and supporting evidence; identifies gaps requiring follow-up.
- Authors, reviews and routes DHF/RMF remediation updates for cross-functional approval under applicable procedures.
- Provides DHF/RMF evidence to support regulatory submissions and inquiries, as assigned.
- Coordinates review of relevant clinical evidence for completeness and alignment with design and risk records.
- Supports Quality and Post-Market Surveillance investigations by reviewing related design and risk records.
- Maintains remediation plans, timelines and status; communicates progress to stakeholders.
- Escalates resource needs, blockers and overdue remediation actions.
- Coordinates cross-functional remediation reviews as needed.
- Tracks action owners, deliverables and due dates through closure.
- Reports remediation status and unresolved issues to leadership.
- Identifies remediation risks, agrees mitigations with stakeholders and escalates issues requiring direction.
Skills:
- Clear written and verbal communication; able to work across functions and regions.
- Design for Six Sigma experience desired
- Microsoft Office Suite software proficiency required
- Experience with medical-device design controls and DHF/RMF remediation preferred; biologics products desirable.
- Working knowledge of ASME GD&T applied to product design required.
- Knowledge of manufacturing processes and materials used in medical-device design and production.
- Knowledge of applicable medical-device quality and regulatory requirements and standards required; global requirements preferred.
- Demonstrated working knowledge of statistics with application to sample size determination, design of experiments and null hypothesis testing preferred; Minitab experience desired
- Proficiency in Cognition Cockpit Platform (Electronic DHF System)
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.
- 3 to 5 years of full-time engineering experience.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN (Remote) |
| Industry | Computer/IT Services |
| Salary | $45 |
| 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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