About the Role

We are looking for an exceptional Sr. Engineer to join our team, and we are considering both senior and intermediate level candidates. He or she will be part of a small and nimble Quality and Regulatory group that is creating revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. You will manage Quality Management System (QMS) responsibilities by working with internal customers and supporting the development and design transfer of medical device products. A strong sense of ownership, great communication skills, and excellent time management skills will ensure success at Magnolia. The team is growing quickly and there will be many opportunities to work in a variety of quality functions.

The right individual to join our team is a self-starter with a dive in and get-it-done approach to trying new ideas, prototyping, and solving problems. He or she will be motivated to create products that work elegantly to solve real clinical problems, help patients, and make the job better and easier for clinicians.

About Us

Magnolia Medical Technologies is a privately held organization, delivering revolutionary solutions to challenges that have long plagued our healthcare system. We are designing and building products that significantly improve patient outcomes. We have launched the innovative and broadly patented Steripath® blood collection system, the only device on the market proven to significantly reduce false positive blood cultures - the standard-of-care for diagnosing sepsis. We have achieved outstanding clinical results and proudly count some of the most respected healthcare systems in the country as early customers. We are offering qualified candidates an opportunity to get in early and help build a company dedicated to improving the health and well-being of millions of people around the world.

Responsibilities:

• Lead as the Quality representative for the Design Controls process, including design input, design V&V activities, design transfer and product realization, and performance in the field to ensure all design requirements are effectively met
• Support cross-functional engineering teams with activities such as design change analysis, design requirements, verification testing methods, protocols and reports and ensure compliance with applicable processes and regulations
• Drive risk management activities in accordance with ISO 14971 (Risk Management Plan, Hazard Analysis, FMEAs, RM Report)
• Responsible for ensuring Design History File and Device Master File documentation is present, compliant, and maintained
• Responsible for managing, investigating, and documenting NCRs and CAPAs within the Quality Management System
• Develop policies and procedures to continuously improve the Quality Management System
• Participate in internal and external audits and regulatory inspections
• Review quality records and documentation

Personal Qualities:

• Strong analytical and problem-solving skills with a highly-oriented process approach (RCA, DMAIC, Six Sigma)
• Strong interpersonal skills, ability to work well with others in both one-on-one interactions as well as team activities
• Excellent oral and written communication skills
• Organized, hands-on, self-motivated, and detail-oriented

Required Skills & Experience:

• Five (5) to eight (8) years of experience in a medical device manufacturing environment, or other regulated industries
• Bachelor’s degree in Engineering or related science field
• Quality Management System and Document Management Experience
• Expertise with 21 CFR 820, ISO 13485, ISO 14971 and EU MDR CE regulatory requirements
• Strong experience with product development, Design Controls and Risk Management
• Experience with process and equipment validations
• Strong process development skills using appropriate (e.g., Process Mapping, Flow Charts, SPIOC, SPC)
• Strong in Microsoft Office and statistical analysis software
• Strong technical writing skills

Benefits:

• Competitive salary, including bonus
• Medical, dental and vision insurance
• 410(k) and stock equity plans
• Hybrid work schedule
• Competitive PTO plan

Magnolia Medical Technologies is committed to the continued development and successful marketing of innovative products that will improve the way healthcare is practiced around the world. We offer competitive compensation based on experience level, along with benefits, career growth opportunities, and incentives (including equity) to the most qualified candidates in the marketplace. Magnolia Medical Technologies, Inc. is an equal opportunity employer.

For more information, visit www.magnolia-medical.com

**As a condition of employment with Magnolia Medical Technologies, you are required to provide proof that you are fully vaccinated against COVID-19 or qualify for a reasonable accommodation.