The Senior Quality Engineer will play a crucial role in ensuring the quality and compliance of SanaHeal’s bioadhesive medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with a small, cross-functional team including R&D, manufacturing, and regulatory affairs to drive excellence in design control processes.

Responsibilities

• Initiate assignments independently. Actively lead and participate in development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
• Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
• Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
• Design Input and Output: Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements. Validate that design outputs meet the specified design input requirements.
• Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
• Verification and Validation: Develop and protocols for design verification and validation strategies and acceptance criteria. Collaborate with testing teams to ensure thorough testing of product designs.
• Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
• Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
• Continuous Improvement: Actively monitor effectiveness of processes and quality of project work, propose, and execute quality/process improvements. Write/review policies/processes/procedures and related documents.

Required Qualifications

• Minimum of 3-5 years of experience in a quality engineering role in the medical device industry.
• Bachelor's degree in engineering or a related field; advanced degree preferred.
• In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
• Strong technical skills related to product quality including Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
• Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.

Other Requirements:

• Mechanical or Manufacturing background strongly preferred.
• Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
• Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls is a plus.
• Computer proficiency in MS office (specifically Excel).
• Effective verbal and excellent technical writing skills.
• Excels at generating and maintaining organized and accurate records.
• Excellent oral and written communication skills in English.
• Able to travel domestically and internationally as required (<10%)
• Able to work in the US without sponsorship now or any time in the future.

Benefits:

• Health/Vision/Dental Insurance - 100% paid by company.
• Commuter Pass if needed – Office located ~5 min walk from East Somerville Green-Line stop
• Parking on site if needed
• Paid holidays and paid vacation
• 401K

SanaHeal is a privately-owned, early-stage company, located in Somerville, MA, in the pre-clinical phase that offers a breakthrough bioadhesive technology platform for revolutionizing the repair and healing of injured tissues and organs. Our first products/indications aim at two long-standing challenges in healthcare – rapid control of surgical bleeding and wound healing – to address unmet clinical demands to benefit millions of patients in the U.S. and worldwide. Beyond our first products/indications, SanaHeal’s unique bioadhesive platform will offer breakthrough solutions for a rapidly expanding list of indications and clinical challenges. SanaHeal was founded on strong synergy from the multi- and cross-disciplinary collaboration between scientists, engineers, and entrepreneurs, and we are excited to welcome a new colleague to join our venture.

Please send your cover letter and resume to job@sanaheal.com with the subject line Application Senior Quality Engineer