Design & Development Quality Engineer II

Forj Medical; Saint Paul (MN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K plan

Annual bonus

Job summary

Forj Medical is seeking a Design and Development Quality Engineer II in Minnesota to drive project quality across devices and systems. You will support verification/validation activities, ensure SOP-compliant processes, and collaborate with cross-functional teams to deliver safe, compliant medical products.

The role requires a engineering degree and 3–5 years in a medical device environment, with knowledge of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304.

Qualifications

• Bachelor’s Degree in Engineering or equivalent experience.
• 3–5 years in a medical device manufacturing/product development environment.
• Understanding of FDA QMSR, ISO 13485, IEC 60601, IEC 62304 requirements.
• Experience with product/process verifications/validations.
• Experience with DFMEAs, PFMEAs, Risk Management, Equipment Qualifications, and Statistical analysis.

Responsibilities

• Participates/Approves in development of requirements, technical reviews, test report development, design transfer coordination/support and FMEA, DFMEA development.
• Participates in project/customer meetings and leads phase reviews.
• Monitors project activities to ensure adherence to Forj Medical processes.
• Collaborates with Supplier Quality to qualify new suppliers and components.
• Supports teammates in resolving constraints and issues.
• Reviews/approves regression analysis, trace matrices, ECOs, DBRs, tool qualifications, test procedures.
• Manages and monitors DDF files and verification reports.
• Monitors test execution, device testing, and safety/EMC test reports.
• Drives design change assessments with cross-functional support.
• Assists in verification test procedures.

Skills

Bachelor’s degree in engineering

3–5 years experience in medical device

FDA QMSR / ISO 13485 / IEC 60601 / IEC

Education

Bachelor’s Degree in Engineering

Tools

Statistical analysis

Job description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary

Design and Development Quality Engineers drive project quality in all areas including all deliverables and ensure that development teams follow processes that are effective and compliant to SOPs. They work with both the customer and internal team members to drive successful outcomes and long-term value for both the customer and Forj Medical. Design and Development Quality Engineer II will work under the direction/supervision of more senior Design QA staff members to ensure resolution of technical issues and knowledge transfer. They assist in the development of verification and validation activities on medical devices and medical device systems. Verification testing may involve GUI testing, black-box system testing, environmental testing, requirements based functional testing and low-level hardware testing and fault simulation.

Job Duties And Responsibilities

• Participates/Approves in development of requirements, technical Reviews, test report development, design transfer coordination/support and FMEA, DFMEA development
• Participates in project/customer meetings and Leads Phase Reviews
• Monitors project activities to ensure following Forj Medical processes.
• Collaborated with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.
• Uses cross functional knowledge to be able to support teammates in constraints arise
• Reviews/Approves regression analysis, Trace Matrix, ECOs, DBRs, DV Tool Qualifications, Test Procedures.
• Manages and monitors Design and Development (DDF) file including creating development planning documents and verification reports.
• Monitors Test Execution Management, Device Testing, Dry Run Status, Stage Build Process Compliance, and Safety/EMC Test Reports
• Drives Design Change assessments including planning and report documentation with cross functional support.
• Assists in the generation and/or execution of verification test procedures.
• Ensures verification configurations tested are production equivalent by collaborating with other engineering disciplines and early stage to build knowledge.
• Other duties as assigned

Required Qualifications

• Bachelor’s Degree/Technical Degree in Engineering or equivalent experience
• 3-5 years’ experience in a Medical Device manufacturing/product development environment
• Understanding of FDA QMSR, ISO 13485, IEC 60601, and IEC 62304 requirements
• Experience/knowledge with product/process verifications/validations
• Experience with DFMEAs, PFMEAs, Risk Management, Equipment Qualifications, and Statistical analysis

Preferred Qualifications

• Certified Quality Engineer (CQE) or equivalent experience
• Must possess good project management skills and initiative in taking on and completing projects
• Must possess good verbal and written communication skills
• Must be able to manage and prioritize multiple projects/objectives
• Strong interpersonal, teamwork, and communication skills.
• Strong written communication demonstrating the ability to simplify complex information.

Working Conditions

• Office environment
• Manufacturing environment

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.