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Job Title: Director of Quality Assurance

Location: Minneapolis, MN

Position Summary: The Director of Quality Assurance will be a key member of the leadership team, responsible for overseeing all quality assurance and supporting regulatory activities. This role requires a strategic leader with a strong background in quality management systems and medical device standards with prior experience in regulatory affairs. The Director will collaborate with cross-functional engineering and clinical teams, to ensure our products are safe, effective, and compliant with all relevant regulations.

Key Responsibilities:

· Develop and implement quality assurance strategies and systems to ensure compliance with regulatory requirements and industry standards.

· Support the preparation and submission of regulatory filings, including U.S. FDA, EU MDR, and other international regulatory bodies.

· Lead internal and external audits, ensuring readiness and compliance with regulatory inspections.

· Establish and maintain quality management systems (QMS) for a clinical stage medical device company in accordance with ISO and other relevant standards.

· Monitor and analyze quality metrics to identify trends and areas for improvement.

· Collaborate with R&D, manufacturing, and clinical teams to ensure quality and regulatory considerations are integrated into product development.

· Provide guidance and training to staff on quality and regulatory requirements.

· Stay current with changes in regulatory requirements and industry best practices, ensuring the company remains compliant.

· Represent the company in interactions with regulatory agencies and industry groups.

Qualifications:

· Bachelor’s degree in engineering, life sciences, or a related field (advanced degree preferred).

· Minimum of 8 years of experience in quality assurance within the medical device industry.

· Preferred experience with quality management systems in companies conducting product development with early feasibility and clinical stage medical devices.

· The preferred candidate will also have demonstrated experience supporting regulatory affairs functions.

· In-depth knowledge of U.S. FDA, EU MDR, and other international regulatory requirements.

· Experience with quality management systems, including ISO 13485.

· Strong leadership, communication, and interpersonal skills.

· Self-starter with the ability to work independently.

· Ability to work effectively in a fast-paced, dynamic startup environment.

· Detail-oriented with strong analytical and problem-solving skills.

Benefits:

· Competitive salary and equity compensation.

· All benefits ordinarily afforded to full-time, exempt employees of the company.

· Professional development opportunities.

· Collaborative and innovative work environment.

Job Title: Senior Research & Development Technician

Location: Minneapolis, MN

Position Summary: The Sr. R&D Tech will have a broad range of responsibilities inclusive of product research, development and manufacturing. Initially this job will focus on product manufacturing and process development to optimize throughput and yield with an increasing focus on product development activities as product design iterates. This role requires a nimble individual who is comfortable taking on a variety of challenges.

Key Responsibilities:

· Build medical devices through the early phases of product development in both a cleanroom and general manufacturing environment.

· Support builds and inspections for human clinical phases.

· Assist in the design of fixtures and procurement of equipment.

· Support test method validation activities including calibration and gauge R&R.

· Design, fabricate, install, operate, and maintain test fixtures.

· Utilize manual and/or automated measurement equipment/tools.

· Accurately draft and optimize test methods and manufacturing procedures.

· Assist in identifying and implementing process improvements including equipment qualifications and documentation.

· Familiar with performing root cause analysis for identified issues with product, equipment, test methods, fixtures, or processes.

· Manage and execute development builds and associated build records.

· Highly skilled in medical device prototyping, troubleshooting, and understanding manufacturing processes.

· Teach and train others to perform manufacturing procedures, test methods, and test protocols.

· Proficient at solving problems in a timely manner.

· Work with a positive attitude and willing to take on a wide range of tasks.

· Ability to work independently.

Qualifications:

· 2-year degree in a technical field (equivalent work experience will be considered).

· 4+ years of experience as a technician supporting product development process from concept to production with a strong focus in Research and Development as well as Process Development and Manufacturing.

· Strong background in assembly, experience working in a cleanroom environment, and knowledge of medical component or device manufacturing.

· Solid technical ability with demonstrated attention to detail.

· Familiar with basic statistics, spreadsheet programs, and statistical software.

· Focus on quality.

· Excellent written and verbal communication skills.

· Ability to work in a small team environment that is fast-paced and dynamic.

· Ability to handle and be trusted with confidential and/or sensitive information.

· Flexible and able to handle multiple tasks in an organized, timely manner.

· Able to solve problems quickly and meet aggressive program timelines.

· SolidWorks experience preferred.

· In addition, this role will have certain physical requirements:

· Prolonged periods of sitting at a desk and working on a computer.

· Prolonged periods of standing.

· Must be able to lift up to 25 pounds at times.

· Possess the manual dexterity to assemble products or machines as directed.

· Must have excellent hand-eye coordination.

· Ability to differentiate between colored wires, tabs, and electronic components.

· Must wear gown, gloves, and ear protection when applicable.

Benefits:

· Competitive salary and equity compensation.

· All benefits ordinarily afforded to full-time, exempt employees of the company including paid holidays and paid time off.

· Professional development opportunities.

· Collaborative and innovative work environment.