Design Quality Engineer

About Northeast Biomedical

Northeast Biomedical (NEB) is an ISO 13485-certified medical device product development and contract manufacturing company specializing in helping innovators transform ideas into commercially successful medical devices. Our multidisciplinary team partners with startups, physicians, entrepreneurs, and established medical device companies to develop technologies from concept through commercialization.

Our work spans a broad range of medical technologies, including cardiovascular devices, surgical instruments, implants, drug delivery systems, diagnostics, and other innovative healthcare products. We combine engineering expertise, quality systems, regulatory knowledge, and manufacturing capabilities to accelerate product development and reduce risk for our clients.

Position Summary

NEB is seeking a Design Quality Engineer to support the development of innovative medical devices within a fast-paced consulting and product development environment. This position reports directly to Phil Andrusin, Vice President of Engineering, and works closely with engineering, manufacturing, quality, and project teams throughout the product development lifecycle.

The Design Quality Engineer will be responsible for ensuring that quality and regulatory requirements are effectively integrated into product development activities from concept through commercialization. This role includes participation in design controls, risk management, verification and validation, product transfer, and quality system improvement initiatives.

Candidates with a wide range of experience are encouraged to apply. The final level, responsibilities, and compensation will be determined based on qualifications, technical expertise, and relevant industry experience.

Responsibilities

• Support and lead design control activities throughout product development programs.
• Develop and maintain Design History Files (DHFs) and supporting quality documentation.
• Participate in product requirements development, traceability, and design review activities.
• Lead or support risk management activities, including hazard analyses, FMEAs, and risk-benefit assessments.
• Collaborate with engineering teams to ensure compliance with applicable regulatory and quality requirements.
• Develop, review, and approve protocols and reports for verification and validation activities.
• Support design verification, design validation, and process validation efforts.
• Review engineering documentation, specifications, drawings, and test reports for quality compliance.
• Participate in change control activities and engineering change assessments.
• Investigate nonconformances and support root cause analysis and corrective action activities.
• Support manufacturing transfer and production readiness activities.
• Participate in internal and external audits.
• Contribute to continuous improvement initiatives within NEB's ISO 13485-certified Quality Management System.
• Interface directly with clients on project-specific quality and regulatory matters as required.
• Support compliance with FDA regulations, ISO standards, and customer requirements.

Qualifications

Required

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Quality Engineering, or a related technical discipline.
• 0-10 years of experience in medical device, biotechnology, pharmaceutical, or other regulated industries.
• Strong technical writing and documentation skills.
• Excellent organizational and project management abilities.
• Strong analytical and problem-solving skills.
• Effective verbal and written communication skills.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Proficiency with Microsoft Office applications.

Preferred

• Experience with medical device design controls.
• Familiarity with ISO 13485 and FDA Quality System requirements.
• Experience developing and maintaining Design History Files.
• Experience with risk management methodologies, including FMEA.
• Experience supporting verification and validation activities.
• Familiarity with statistical analysis and quality engineering tools.
• Experience supporting audits, CAPA activities, and quality system improvements.
• Familiarity with IEC, ISO, FDA, and other applicable medical device standards and regulations.

Position Level

NEB is seeking candidates across a broad range of experience levels. Individuals early in their careers who are eager to learn and experienced quality professionals looking for greater technical responsibility are both encouraged to apply.

The final title, responsibilities, and compensation package will be commensurate with experience, demonstrated technical capability, and industry expertise.

Why Join NEB?

• Work on a diverse portfolio of innovative medical device technologies.
• Gain exposure to the entire product development lifecycle.
• Collaborate with experienced engineers, scientists, and manufacturing professionals.
• Work directly with company leadership and technical experts.
• Contribute to products that improve patient outcomes and quality of life.
• Join a growing organization with opportunities for professional advancement and leadership development.

Benefits

NEB offers a competitive compensation and benefits package, including health insurance, paid time off, retirement savings opportunities, professional development support, and participation in a collaborative, innovation-focused work environment.

Northeast Biomedical is an Equal Opportunity Employer and values diversity in the workplace.