Principal Reliability Engineer

Bracco Medical Technologies; Eden Prairie (MN); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Paid Time Off

Company Holidays

401k matching

Tuition reimbursement

Medical, dental, vision insurance

Job summary

Bracco Medical Technologies in Eden Prairie, MN seeks an experienced Reliability Engineer to lead Design for Reliability (DFR) efforts across hardware and software, mentor engineers, and integrate reliability into product development. You will define metrics, drive root-cause investigations, and collaborate with quality and regulatory teams to ensure ISO 13485 compliance and risk management.

Travel ~10% may be required.

Qualifications

• Bachelor's degree in engineering with relevant systems, electrical, mechanical, biomedical, or software focus.
• Experience mentoring engineers and guiding test protocols, system tests, and reports.
• 5+ years in Design for Reliability (DFR) and product development system engineering.
• Experience analyzing field, complaint, and service data for reliability trends.
• Strong RCA experience with corrective actions for complex failures.
• Knowledge of reliability, risk management, and design controls (ISO 14971/13485).
• Ability to communicate across the enterprise and build productive relationships.
• Excellent organizational skills and multi-tasking in a cross-functional team.

Responsibilities

• Define and lead DFR methodologies to support hardware and software product development.
• Mentor engineers to improve skills, methodologies, and domain knowledge.
• Develop business cases and plans for reliability programs; present to senior management.
• Review and approve reliability planning, testing and analysis in NPD and sustaining programs.
• Ensure quality and reliability requirements are incorporated across products.
• Contribute to Technical Design Reviews to ensure completeness and effectiveness.
• Define strategy for new tools and processes addressing reliability needs.
• Advocate reliability in business and customer interactions.
• Attract, develop, and retain engineering talent; guide engineers in design reviews.
• Communicate technical updates to stakeholders; manage risk decisions to closure.
• Define reliability metrics and targets using field, complaint, service, and test data.
• Lead investigations for significant field failures and drive improvements.
• Provide reliability input to risk management decisions.
• Measure subsystems and end-to-end reliability to demonstrate customer impact.

Skills

DFR methodologies

Mentoring

Root cause investigations

Data analysis

Systems engineering

Risk management

ISO 14971 / ISO 13485

Communication

Cross-functional leadership

Education

Bachelor's in engineering

PhD in EE / Systems / Reliability

Tools

Project management tools

Job description

Primary Duties and Responsibilities:

• Define and lead Design for Reliability (DFR) methodologies and framework that supports new product development across hardware and software
• Mentor engineers to improve engineering skills, methodologies, and domain knowledge
• Develop the business case and plan for reliability programs and communicate benefits to senior management in the engineering and quality organizations
• Review and approve reliability planning, testing, and analysis activities within both New Product Development and sustaining programs
• Ensure quality and reliability requirements are incorporated into BMT products, and construct useful methods to quantify product quality and reliability across the portfolio
• Contribute to the execution of Technical Design Reviews to ensure they are complete and effective
• Develop and define the strategy and roadmap for incorporating and deploying new tools, methods, and processes to address the quality and reliability needs of BMT
• Be a technology advocate in business and customer interactions
• Attract, develop, and retain engineering talent
• Be the champion and key stakeholder in the technical design reviews for products in the portfolio while providing opportunities and guidance to engineers in presenting and explaining technology designs and how decisions were made.
• Take responsibility for internal and external stakeholder communication on key technical updates and issues, adapting the message to ensure effective communication to different audiences.
• Effectively manage risk management activities and ensure decisions are made, implemented and tracked to conclusion for technical issues throughout the project.
• Define reliability metrics and targets using field, complaint, service, and test data
• Lead and/or support reliability investigations for significant and recurring field failures and drive product reliability improvements based on post-market performance
• Drive
• Provide reliability input to risk management and risk-control decisions
• Measure subsystem and end-to-end system reliability to demonstrate customer impact

Qualifications (Knowledge, Skills & Abilities):

Minimum

• Bachelors’ degree in engineering, preferably systems, electrical, mechanical, bio-medical, or software, reliability, or related scientific discipline
• Experience mentoring and coaching engineers. (i.e., Ability to coach and guide others how to develop protocols, execute system tests and write effective reports)
• 5+ years of experience with the Design for Reliability (DFR) and associated reliability processes
• 5+ years in a product development system engineering role
• Experience analyzing field, complaint, and service data to identify reliability trends and failure modes.
• Demonstrated experience leading root cause investigations in partnership with engineering and quality and corrective actions for complex product failures
• Working knowledge ofreliability, risk management, and design controls, including ISO 14971 and ISO 13485
• Demonstrated experience with risk management and systems engineering processes
• Ability to grow productive, trusting, and open relationships with a wide variety of constituencies
• Demonstrated ability to communicate effectively across a business enterprise, adapting your message to the audience in both written and verbal media
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize work for self and team effectively
• Ability to work both independently and as part of a team across the business unit

Preferred

PhD in EE, Systems Engineering, , Reliability, SW, Physics, or related scientific discipline

• 10+ years of Reliability experience
• Experience working with physicians and customers in a product development role
• Demonstrated capability gathering and distilling Voice-of-customer experience to actionable items within a product development team
• Experience in developing and interpreting clinical research to advance capabilities and claims of medical devices
• Demonstrated ability to transition technology research into commercial product offerings
• Demonstrated ability to coach, teach, and grow early career engineers into senior positions
• Experience with design of experiments, data analysis, statistical methods & presentation of results
• Familiarity with functional database and software tools for managing projects, requirements, risk, etc.
• Understanding of product development milestones and basic business financials
• Experience with government regulatory agencies and audit processes (i.e. FDA, FAA, NRC, etc.)
• Experience in Reliability /Serviceability as applicable to medical equipment
• CRE, ASQ or Six Sigma certification as a Black Belt or Master Black Belt

Other

• Ability to Travel ~10%

Compensation & Total Rewards:

*Estimated salary is intended to reflect the salary Bracco Medical Technologies reasonably expects to pay for the position. The provided range is based on salary and market data and may vary based on an employee's eligibility for geographic differential pay in high-cost-of-labor markets.

Total Rewards:

• Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
• Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
• Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
• Choose –You won’t find “stuffy” here whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

Bracco Medical Technologies is an Aff…