Senior Development Engineer

Duration: 12+ Months

Location: IN-Warsaw, 100% Remote

Overview: Every Turnberry consultant belongs to a practice, an internal group of consultants and leaders with shared experience and expertise. Each of these practices aligns to one of the core services Turnberry offers to clients. As a Senior Development Engineer, you will join Turnberry's Digital Modernization practice, where technology and strategy combine to deliver exceptional digital experiences, empowering organizations to thrive in today's digital market.

• Apply product, clinical, regulatory, and standards knowledge to legacy DHF/RMF remediation
• Review available user needs and intended-use documentation for completeness and consistency
• Check traceability among user needs, design inputs, outputs, and supporting verification/validation evidence; documents gaps for remediation
• Review design rationale and supporting records; update documentation to address identified gaps
• Identify and coordinate retrieval of objective evidence needed to complete DHF/RMF records
• Coordinate with cross-functional teams to locate and assess design verification, validation, and process-validation evidence
• Review production specifications and inspection records for completeness and consistency with design documentation
• Link critical-to-quality features and inspection evidence to applicable design requirements and risks
• Review design verification, validation, and risk-control evidence against requirements and applicable procedures
• Partner with Quality, Regulatory, Manufacturing, and Sourcing to resolve documentation gaps and obtain approvals
• Assess test-method documentation and supporting evidence; identify gaps requiring follow-up
• Author, review, and route DHF/RMF remediation updates for cross-functional approval under applicable procedures
• Provide DHF/RMF evidence to support regulatory submissions and inquiries, as assigned
• Coordinate review of relevant clinical evidence for completeness and alignment with design and risk records
• Support Quality and Post-Market Surveillance investigations by reviewing related design and risk records
• Maintain remediation plans, timelines, and status; communicate progress to stakeholders
• Escalate resource needs, blockers, and overdue remediation actions
• Coordinate cross-functional remediation reviews as needed
• Track action owners, deliverables, and due dates through closure
• Report remediation status and unresolved issues to leadership
• Identify remediation risks, agree mitigations with stakeholders, and escal​ate issues requiring direction

• 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)
• Minimum B.S. degree 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

The salary range for this role is $55,000 to $85,000…