Permobil · 14 hours ago
Director, Design Assurance
Lebanon, TN
Full-time
Onsite
Director/Executive
7+ years expPermobil is a global leader in advanced rehabilitation technology, focused on creating innovative assistive solutions for individuals with disabilities. The Design Assurance Director is responsible for ensuring quality and regulatory compliance in the design and development of medical devices, leading a team to uphold design control practices and collaborate with cross-functional teams.
Health CareInnovation ManagementManufacturing
Responsibilities
Lead and develop a high-performing global Design Assurance team, driving a strong quality-by-design culture and effective collaboration with R&D
Ensure compliant design control execution across the product lifecycle in accordance with FDA 21 CFR 820.30, ISO 13485, EU MDR, including DHF and MDF ownership
Drive clear, testable, and traceable design inputs and outputs aligned with user needs, risk management (ISO 14971), and industry best practices
Act as a Design Assurance subject matter expert, guiding V&V strategies, statistical methods, and regulatory-grade documentation for hardware, software, and systems
Partner with Product Owners and R&D within Agile frameworks to embed quality and regulatory requirements into backlogs, sprints, and design reviews
Oversee compliant design change and lifecycle management, supporting design transfer, post-market changes, and cross-functional implementation
Standardize and modernize global design assurance processes, tools, and templates while contributing to long-term Quality & Regulatory strategy
Qualification
Required
Bachelor's or Master's degree in Engineering, Science, or related technical field
7+ years of experience in medical device R&D, quality engineering, or design assurance
Strong working knowledge of FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971, and design control best practices
Experience in both hardware and software product development environments
Experience at major med-tech organizations or similar high-regulation environments
Working knowledge of IEC standards for medical electrical equipment or software (e.g., IEC 60601, IEC 62304)
Strong statistical knowledge and experience with V&V sampling methodologies
Experience implementing or supporting global design assurance frameworks
Demonstrated success partnering with engineering teams in an Agile development model
Preferred
3+ years of leadership or people management experience is preferred
Benefits
You’ll make a difference. Every day.
You’ll make your mark as part of our future
You’ll feel welcome from day one
You can have a lifestyle you love
Company
Permobil
Permobil creates assistive solutions that enrich the lives of people living with disabilities.
1001-5000 employees
H1B Sponsorship
Permobil has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (11)
2023 (3)
2022 (2)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
unknown2013-03-27Acquired
Leadership Team
Chuck Witkowski
Chief Executive Officer
Charlotta Nyberg
Group Chief Financial Officer
Recent News
2025-10-28
AstuteAnalytica India Pvt. Ltd.
2025-10-23
Company data provided by crunchbase