Senior Design Assurance Engineer

Overview

Position Summary

The Quality Engineer is responsible for maintaining and improving the quality of Tactile Medical products and processes and improving supplier management and performance.

Responsibilities

Accountabilities & Responsibilities

• Lead design assurance activities throughout the product lifecycle, from concept development to commercialization and post-market surveillance.

• Collaborate with cross-functional teams to ensure design inputs are clearly defined and translated into robust design outputs.

• Support verification and validation activities (including software validation) to demonstrate product performance and compliance with regulatory requirements (e.g., FDA, ISO).

• Lead risk analysis activities to identify and mitigate potential hazards associated with product design and manufacturing processes and maintain Risk Management File.

• Establish and maintain design control procedures, ensuring adherence to applicable standards and regulations.

• Lead and implement complex projects including quality improvement initiatives.

• Support change control activities for established products.

• Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits.

• Foster a culture of quality and compliance within the organization by promoting awareness and adherence to relevant policies and procedures.

Qualifications

Education & Experience

• 5+ years of experience as a Quality Engineer within the medical device industry

• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

Knowledge & Skills

• Strong understanding of design control principles, FDA regulations (e.g., 21 CFR 820), and international standards (e.g., ISO 13485).

• Proficiency in risk management methodologies and tools (e.g., FMEA, fault tree analysis).

• Experience with verification and validation activities, including test method development and execution.

• Excellent analytical and problem-solving skills, with the ability to prioritize and manage multiple tasks in a fast-paced environment.

• Effective communication and interpersonal skills, with the ability to collaborate effectively across diverse functional teams.

• Detail-oriented mindset with a commitment to upholding high standards of quality and compliance.

• Familiarity with design and analysis tools (e.g., CAD software, statistical software) is desirable.

It is the policy of Tactile Medical to provide equal opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Tactile Medical will provide reasonable accommodations for qualified individuals with disabilities.

Below is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

$91,800 - $128,520

Additional benefits:

exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.