Associate Compliance Engineer

Associate Compliance Engineer Opportunity

Looking to make a difference in the MedTech industry? At MethodSense, we help companies bring lifechanging technologies to market—faster and with greater confidence. MethodSense, Inc. is a medical device and combination product regulatory affairs and quality assurance advisory firm. We are deeply committed to driving the business value of our clients through developing and implementing regulatory strategies, quality systems, operational, and technology processes. 

OPPORTUNITY MethodSense is seeking to grow its incredible team of professional consultants with people who want to be a part of effective working teams, an environment that can accelerate their professional careers, and make a direct impact that benefits patients and health care providers in the field of medical device consulting. If you want to join a team that thrives on clarity, innovation, and impact look no further. As an Associate Compliance Engineer, you will support critical customer projects. In this role, you will be responsible for learning and applying basic project management principles in order to meet businesscritical deadlines while maintaining attention to detail in document creation and review. The Associate Compliance Engineer role is an amazing opportunity to learn and adhere to establish processes and quality standards while growing your technical skills and subject matter expertise in Quality Management Systems and FDA regulations for medical devices. Reporting to the MethodSense Executives and experienced team leaders in support of customer projects, this is a crucial role on our team! 

RESPONSIBILITIES The Associate Compliance Engineer/Consultant assists in Quality Project tasks and assignments to support: 

• The development of elements of client Quality Management Systems, utilizing provided templates and step-by-step guidance. 

• The implementation of Quality Management System procedures by creating quality records following detailed client procedures and work instructions. 

• Preparation for client internal audits by reviewing straightforward records against clearly defined acceptance criteria. 

• The review of medical device requirements and specifications under close supervision. 

• The creation of Design History File documents using established templates and detailed work instructions.

The Associate Compliance Engineer/Consultant also contributes to Regulatory Project tasks under close supervision and mentorship to support: • The creation of regulatory assessments. 

• Assisting with the organization of regulatory submissions. • Participation in risk assessments. 

• Supporting verification and validation activities by following detailed protocols. • Taking notes during regulatory meetings and drafting meeting minutes for review. 

• Assisting in the preparation of presentation materials using provided templates. 

REQUIREMENTS MethodSense is more than a consulting firm—it’s a close-knit, values-driven team that acts as an extension of its clients’ organizations. The company emphasizes accountability, integrity, and knowledge, helping medical device innovators bring life-changing technologies to market.  The successful candidate will show potential for growth in the field of quality engineering and regulatory affairs, with a strong desire to learn and contribute to the team's success. 

Education and Experience: 

• Bachelor's degree in biomedical engineering, engineering, or related scientific field. 

• 0-1 year of related experience; internships or co-op experience a plus • Familiarity with medical device industry concepts (through coursework or internships) 

• Basic understanding of quality management principles • Fundamental project management skills 

• Proficiency in Microsoft Office suite

Professional & Personal Characteristics: 

• Eager to learn and develop professional skills 

• Detail-oriented and committed to producing high-quality work 

• Strong written and verbal communication skills 

• Ability to follow instructions and adhere to established processes 

• Team player with a positive attitude 

• Time management skills and ability to meet deadlines 

• Proactive in seeking clarification and guidance when needed 

• Demonstrates intellectual curiosity about the medical device industry 

WHAT WE OFFER 

• High-impact projects with leading MedTech innovators 

• Cross-functional collaboration with regulatory, quality, and technical experts 

• Opportunities for learning, growth, and thought leadership 

• Company-paid medical insurance 

• 15 Vacation Days and 10 Holidays 

• Performance Based Bonus Plan 

• 401k contribution of 3% after a year of employment

• Remote-friendly, flexible work environment 

OUR COMMITMENT

At MethodSense, we have a commitment to diversity and inclusion, recognizing that a variety of perspectives and backgrounds is critical to our success. MethodSense provides equal employment opportunities (EEO) to all employees and applicants for employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, status as a covered veteran, or other protected class in accordance with applicable federal, state and local laws. All employment decisions are based on qualifications, merit, competence, and experience, not on protected characteristics.