Director of Design for Reliability - Medical Device (Plymouth, MN)

Job Title

Director of Design for Reliability - Medical Device (Plymouth, MN)

Job Description

Director of Design for Reliability - Medical Device (Plymouth, MN)

You will be leading the efforts for ensuring the reliability and robustness of our Image-Guided Therapy Systems used in cardiac or vascular medical diagnosis and treatment.  Your role will be pivotal in developing and integrating the DFR mindset into the design process to create products that meet the highest standards of performance, safety, and reliability, ultimately improving patient outcomes and enhancing the efficiency of healthcare delivery.

Your role:

• Strategic Leadership, Team Management & Cross-Functional Collaboration: Develop and execute strategies to embed DFR principles into the design and development process of IGT-S systems, aligning with overall business objectives.  Lead and mentor a multidisciplinary team of reliability/design/test engineers and analysts, fostering a culture of innovation, collaboration, and continuous improvement. Collaborate closely with R&D, product management, quality assurance, and other stakeholders to integrate reliability considerations throughout the product lifecycle including the design and manufacturing phases.

• Risk Assessment, Mitigation & Reliability Testing: Identify and assess potential failure modes and risks associated with product design and implement proactive measures to mitigate these risks.  Oversee the development and execution of comprehensive reliability testing protocols, including accelerated life testing, stress testing, and failure mode analysis.

• Data Analysis / Insights & Regulatory Compliance: Utilize data analytics and predictive modeling techniques to extract insights from reliability testing results and drive data-driven decision-making. Ensure compliance with relevant regulatory standards and requirements pertaining to product reliability and safety.

• Continuous Improvement: Establish metrics and KPIs to measure the effectiveness of DFR initiatives and drive continuous improvement efforts to enhance product reliability and performance.

• Knowledge Sharing and Training: Promote knowledge sharing and provide training to the organization on best practices in reliability engineering and design for reliability.

You're the right fit if:

• You’ve acquired 15+ years experience in product development and implementing DFR principles within FDA regulated medical device (ISO 13485) or other highly regulated industries and a minimum of 5+ years in strategic program and/or functional leadership

• Your skills include expertise/detailed knowledge of reliability engineering tools and methodologies, including Fault Tree Analysis (FTA), Highly Accelerated Limit Testing (HALT), Accelerated Life Testing (ALT), Design Failure Mode and Effect Analysis (DFMEA/FMEA), Root Cause Analysis (RCA), Mean Time Between Failure (MTBF), Mean Time to Failure (MTTF), Environmental Testing and Design for Reliability (DfR)

• You have an advanced degree in Engineer or other technical discipline and experience in Data Analysis, utilizing the ReliaSoft Suite of tools or similar tools.

• You’re a proven leader of reliability engineering teams and driving reliability initiatives in a complex technical environment, preferably within the medical device or healthcare industry

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. Travel up to 30%.

How we work together 

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. 

  

This is an office-based role. 

  

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality o