Design Quality Engineer

TekWissen; Visakhapatnam District; Remote; INR 5,194,000 - 7,790,000; Full time

Job summary

TekWissen is seeking a Design Quality Engineer for remote assignment. The engineer will remediate DHF/RMF files, strengthen traceability across design records, and support design controls and quality activities for medical-device projects.

Key responsibilities include coordinating with global teams, reviewing evidence, and preparing documentation for regulatory submissions. Strong ASME GD&T knowledge and Minitab skills are preferred, with 3–5 years of related experience.

Qualifications

• This role requires depending on remediation of DHF/RMF and validation records.
• Experience with design controls in medical devices and regulatory alignment is preferred.
• Strong documentation and cross-functional collaboration skills required.

Responsibilities

• Remediate existing DHF/RMF documentation and close gaps.
• Ensure traceability among user needs, design inputs/outputs, and verification/validation evidence.
• Coordinate with cross-functional teams to gather design verification data.
• Review production specs and inspection records for alignment with design docs.
• Route remediation updates for cross-functional approvals and regulatory submissions.

Skills

Clear communication

Design for Six Sigma

MS Office proficiency

Medical-device DHF/RMF remediation

ASME GD&T knowledge

Manufacturing processes knowledge

Regulatory requirements knowledge

Statistics knowledge

Cognition Cockpit Platform

Education

ABET-accredited B.S. in Mechanical/Bioengineering etc.

Tools

Minitab

Cognition Cockpit Platform

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: Design Quality Engineer

Location: Remote
Duration: 6 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.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.