Individuals who excel in fast-paced environments and are committed to completing projects that meet regulations and expectations.Analytical Problem Solvers:
Professionals who look beyond immediate fixes, identifying root causes, evaluating optimal solutions, and recommending improvements to prevent future issues.Collaborative Partners:
Team players who build and leverage cross-functional relationships to synthesize ideas, information, use cases, and industry insights to develop best practices.
What you will do:
Technical Responsibilities:
• Lead technical team members in research, design, development, modification and evaluation of modules, assemblies, or subsystems
• Apply advanced engineering theories, principles, and concepts across various products within business
• Translate user needs to design inputs/ specifications and produce system/architectural level layouts and platform designs
• Assess new technologies and capabilities (prototyping, testing, et.al.) for the organization
• Mentor and influence in correction of complex product design issues
• Navigate the Intellectual landscape for filings and protection
Business Responsibilities:
• Possess an in-depth knowledge of the industry and competitive landscape
• Partner with customers, internal and external key opinion leaders to develop technical strategies that meet clinical needs
• Strategize and execute customer facing activities like voice of customer and customer centric design across the business
• Collaborate on Financial /business modeling and supports business reviews to validate a technical approach
Med Device Compliance:
• Divisional expert with extensive experience applying industry standards for device development
• Independent reviewer and advisor for the creation or refinement of engineering documentation, such as the Design History file
• Lead the development of standards and regulations, working closely with functions within and across business
General Responsibilities:
• Lead cooperative efforts with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
• Lead and support team members to create or improve procedures, policies, processes, systems, and technology requirements
• Develop and utilize tools to enhance the company’s product/process development or performance
• Identify and implement design and process solutions and ensures they are sustained over time
• Lead and support complex product development for cross functional teams, influencing multiple technical areas of expertise
• Hold team accountable to deliver high quality results with passion, energy and drive to meet business priorities
• Mentor, develop and influence across the business, intentionally building divisional relationships
What You Need:
Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 12+ years of work experience
Preferred Qualifications (Strongly desired):
Technical Skills:
• Broad base of experience in Implementing design methodologies such as DFM, Reliability, Systems Design
• High degree of experience in medical device design (or designing in a highly regulated industry) and ability to utilize Solid Modeling and CAE tools to optimize the design
• In-depth knowledge of materials, manufacturing and processing methods and technologies to support complex product development
• Ability to communicate complex plans and technical information to team members within and across businesses