Design Assurance Manager

Talencio; Saint Paul (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

An innovative medical device startup is seeking a Design Assurance Manager to drive quality and compliance efforts. In this pivotal role, you will lead a dynamic team, ensuring that products meet the highest standards from concept to commercialization. This hands-on position offers the chance to influence quality strategies while collaborating with cross-functional teams in a fast-paced environment. If you are passionate about product quality and eager to make a significant impact in the medical field, this opportunity is perfect for you. Join a team where your expertise can truly shape the future of medical devices and enhance patient safety.

Benefits

Competitive compensation

Career growth opportunities

Collaborative work environment

Dynamic work culture

Qualifications

• 10+ years in medical device quality, design assurance, or regulatory compliance.
• Strong expertise in medical device standards and risk management processes.

Responsibilities

• Lead and develop a high-performing Design Assurance team.
• Oversee design verification and validation to ensure product safety.

Skills

Leadership & Influence

Problem-Solving Mindset

Collaboration & Communication

Adaptability & Agility

Strategic Thinking & Execution

Education

Bachelor’s degree in Engineering

Master’s or PhD in Engineering, Mathematics, or Statistics

Tools

JMP

SolidWorks

Minitab

Job description

Design Assurance Manager

This range is provided by Talencio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$120,000.00/yr - $180,000.00/yr

Are you a hands-on leader passionate about ensuring the highest product quality standards, patient safety, and compliance? Do you thrive in a fast-paced startup environment, where your expertise can shape the future of medical devices? If so, our client — a scaling pre-commercial medical device startup — is seeking a Design Assurance (DA) Manager to lead their quality and design assurance efforts.

POSITION SUMMARY

The Design Assurance (DA) Manager will lead quality, risk management, and design assurance activities, ensuring compliance with regulatory standards and the highest product quality. This is a hands-on, player-coach role responsible for setting strategy, supporting execution, and managing key projects. If you enjoy being both a leader and a doer, this is the perfect opportunity to make a meaningful impact.

As a key leader on the Regulatory & Quality Assurance team, you will be pivotal in ensuring that capital, reusable, disposable, and software-based medical device products meet the highest industry standards from concept to commercialization.

This role offers significant opportunities for professional growth, providing exposure to broader regulatory and quality strategies in a fast-paced, dynamic environment.

RESPONSIBILITIES

Lead & Develop the DA Function:

• Build, mentor, and lead a high-performing Design Assurance team.
• Champion a culture of technical excellence, ownership, and continuous improvement.
• Partner with R&D to ensure design control processes drive efficient, high-quality product development.
• Balance strategy with hands-on execution, providing both direction and tactical support.

Own Design Assurance & Compliance:

• Oversee design verification and validation (V&V) to ensure product safety and effectiveness.
• Implement and manage risk management processes per ISO 14971 & IEC 60601.
• Lead failure analysis, root cause investigations, and corrective/preventive actions (CAPA).
• Drive data-driven quality decisions using statistical analysis (JMP preferred).

Enhance Processes & Drive Innovation:

• Standardize and optimize quality tools & statistical methodologies across the Quality Management System (QMS).
• Ensure seamless integration of risk management, usability engineering, and design controls.
• Improve efficiency in design verification & validation through automation, real-time data visibility, and analytics.
• Own and drive key quality initiatives, ensuring both strategic alignment and operational execution.

Collaborate Across Teams to Deliver Excellence:

• Work closely with Regulatory, R&D, and Manufacturing to ensure a seamless transition from design to production.
• Support supplier quality initiatives, ensuring components meet design and performance standards.
• Lead design reviews, risk assessments, and product release processes.

QUALIFICATIONS

Required Qualifications:

• 10+ years in medical device quality, design assurance, or regulatory compliance.
• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
• Strong expertise in medical device standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820, IEC 60601).
• Experience leading design verification, validation, risk management, and CAPA processes.
• Data-driven mindset—proficient in statistical analysis and quality tools (JMP preferred).
• Proven ability to balance strategy with hands-on execution.

Preferred Qualifications:

• Master’s or PhD in Engineering, Mathematics, or Statistics.
• ASQ CQE, Six Sigma Black Belt, or other quality-related certifications.
• Proficiency in SolidWorks or similar engineering tools.

Technical Skills:

• Expertise in medical device design controls, verification & validation (V&V), and regulatory compliance.
• Strong knowledge of ISO 13485, ISO 14971, IEC 60601, and FDA 21 CFR Part 820.
• Advanced proficiency in statistical analysis and modeling (JMP, Minitab, or equivalent tools).
• Experience with failure analysis, root cause investigation, CAPA, and risk management methodologies.
• Familiarity with design for reliability (DFR) and advanced quality tools (FMEA, DOE, APQP, PPAP).

Power Skills (Soft Skills):

• Leadership & Influence: Ability to lead cross-functional teams, mentor staff, and drive quality initiatives.
• Problem-Solving Mindset: Strong analytical thinking to solve complex technical challenges.
• Collaboration & Communication: Ability to partner with R&D, Regulatory, and Manufacturing to ensure alignment.
• Adaptability & Agility: Thrives in fast-paced startup environments with evolving priorities.
• Strategic Thinking & Execution: Ability to set quality strategy while also driving hands-on execution.

What You Can Expect:

• Dynamic, fast-paced environment with opportunities to make a direct impact.
• Cross-functional collaboration with top-tier engineering and quality professionals.
• Competitive compensation & benefits with room for career growth.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Quality Assurance

Industries

Medical Equipment Manufacturing