Design Assurance Engineer II

Acist Medical Systems Inc.; Eden Prairie (MN); On-site; USD 95,000 - 104,000; Full time

Benefits offered by this job

Paid Time Off

401(k) contributions

Medical, dental, and vision insurance

Job summary

Acist Medical Systems Inc. is hiring a Design Assurance Engineer II in Eden Prairie, Minnesota. The role focuses on ensuring compliance with design control procedures and provides expertise in quality assurance for medical devices.

Applicants should have a minimum of 3 years in Quality Engineering and a Bachelor's degree in Engineering or Computer Science. The position offers competitive compensation and a hybrid work model.

Qualifications

• Minimum of 3+ years of Quality Engineering experience in the medical device industry.
• Strong written and verbal communication skills.
• Advanced problem-solving skills.

Responsibilities

• Provide direction to product development teams for medical devices.
• Drive the Design Control process for compliance.
• Conduct routine communication with peers and supervisors.

Skills

ISO 13485 knowledge

Quality Engineering experience

Problem-solving skills

Communication skills

Risk management knowledge

Education

B.S. in Engineering or Computer Science

Tools

Six Sigma

FMEA

DOE

Job description

Position Overview

Design Assurance Engineer II – responsible for supporting design assurance activities for Bracco Medical Technologies (BMT) products, ensuring compliance with BMT design control procedures and applicable regulations.

Primary Duties & Responsibilities

• Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements for medical devices or software as a medical device (SaMD).
• Drive the Design Control process and own the Design and Development File (DDF) within regulatory requirements.
• Ensure specifications and requirements are relevant, capable, include essential elements, meet applicable standards, and are testable and verified.
• Guide and support design verification and validation activities.
• Assess protocols and reports for test robustness, traceability to requirements, statistical sample sizes, and quality of test specifications.
• Lead risk management activities from planning, analysis, verification, risk reporting, and acceptance for assigned areas.
• Support testing qualification, technical standards interpretation, and statistical methods including sample size determination.
• Generate QA deliverables to meet project scope and plan.
• Review, provide input, and approve project-related deliverables and change orders.
• Collaborate with external design/test organizations to meet Design Control requirements and supplier controls.
• Document and report defects found during testing or post‑market activities; provide risk assessment and work with development team to resolve them.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Prepare technical sections of regulatory approval applications by identifying needed testing to support global submission, including U.S. and non‑U.S. product and safety standards.
• Maintain rigorous documentation for all phases of new product development, including specifications, verification/validation test plans, and change orders.
• Conduct routine communication with peers and supervisors, documenting work, meetings, and decisions.

Qualifications

• Minimum B.S. in Engineering (electrical or mechanical), Computer Science, or comparable science discipline.
• Minimum of 3+ years of Quality Engineering experience in the medical device industry.
• Advanced working knowledge of ISO 13485 quality system requirements and FDA quality system regulations (21 CFR 820).
• Working knowledge of quality tools such as Six Sigma, DOE, process analysis/capability, FMEA, FTA.
• Knowledge of risk management and ISO 14971.
• Strong written and verbal communication skills; ability to translate ideas and technical information across all organization levels.
• Advanced problem‑solving skills.
• Ability to develop and deliver clear, concise, timely oral and written reports to peers and management.
• Ability to work independently.

Preferred Qualifications

• Advanced degree in Electrical Engineering or Computer Science.
• Quality Engineering experience with medical devices incorporating electrical, mechanical, and software components.
• Project management skills for planning, conducting, and implementing system assessments.
• Experience handling customer, regulatory agency, or business community inquiries or complaints.
• Knowledge of IEC 60601 and UL Standards.
• Proficiency in applying AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002‑1, and related standards for software validation.
• Experience with 21 CFR Part 11, IPSE GAMP, ISO 14971, 21 CFR Part 11, and other guidance related to software validation.
• Familiarity with SDLC processes and Agile methods for medical device software development.
• Experience with cybersecurity, HIPAA regulations, GDPR, and related data protection policies.

Travel Requirements

Ability to travel domestically and internationally, at times overnight; travel is expected to be less than 10% of the time.

Compensation & Total Rewards

Estimated Starting Salary Range: $95,000 – $104,000.

• Paid Time Off, Company Holidays, and 100% paid family leave options.
• Annual incentive plan and 401(k) savings plan contributions.
• Medical, dental, vision, and life insurance; employer HSA contributions.
• Employee assistance program, short‑term disability, and other comprehensive benefits.
• Structured on‑the‑job learning, workshops, seminars, and tuition reimbursement program.
• Hybrid or in‑office working arrangement with business‑casual attire and schedule flexibility where possible.

EEO Statement

Bracco Medical Technologies is an affirmative action/equal opportunity employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings. We do not discriminate based on age, color, handicap, national origin, or any other factor protected by law.