Engineering - Engineer, Engineering - Individual Contributor

Inte Pros is actively seeking a Medical Device Engineer to join one of our clients in Tempe, Arizona. This is an exciting opportunity for an engineering professional to contribute to the design, development, verification, and commercialization of innovative medical device products.

The ideal candidate will have experience working in a regulated medical device environment and be comfortable collaborating across R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams.

• Research, design, develop, modify, and verify components and systems for medical devices with minimal supervision.
• Translate user needs into design inputs and product specifications while developing system-level designs.
• Develop and analyze engineering solutions, including prototyping one or more concepts to establish proof of concept.
• Apply engineering principles, practices, and procedures to solve complex technical problems.
• Support root cause analysis, identify potential solutions, and evaluate solutions against established requirements.
• Develop bench testing methods and test fixtures to support verification and validation activities.
• Conduct measurement system analysis and develop Design of Experiments (DOE).
• Conduct research, engineering studies, and technical assessments to support product design and development.
• Utilize CAD/CAE tools to support product design, modeling, and detailed engineering documentation.
• Create and review material and component specifications, bills of materials, and other engineering documentation.
• Design, validate, and support the commercialization of new products, considering effectiveness, cost, reliability, safety, and manufacturability.
• Collaborate with manufacturing partners, contract manufacturers, designers, and product specialists to optimize designs for manufacturability.

• Develop an advanced understanding of customer needs and translate those needs into robust and appropriate design inputs.
• Develop proficiency in the product's intended use and applicable clinical procedures.
• Support Voice of Customer activities with internal stakeholders and clinicians to better understand customer requirements.
• Apply knowledge of customer needs and clinical use cases throughout the product development process.
• Understand how engineering and design decisions can affect production metrics, including cost of goods sold (COGS), yield, and manufacturability.
• Develop an understanding of relevant business and financial models.
• Communicate technical information, project plans, and engineering decisions effectively with team members, project managers, and leadership.

• Apply fundamental industry standards, design requirements, and test strategies applicable to medical device regulatory requirements.
• Create and refine engineering documentation, including Design History File (DHF) documentation.
• Follow established R&D procedures, including design controls, risk management, and other requirements within the company's Quality Management System (QMS).
• Ensure engineering activities and deliverables comply with applicable procedures and regulatory expectations.

• Work with minimal supervision while collaborating closely with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams.
• Quickly learn and apply procedures, policies, processes, systems, and technologies required for assigned projects.
• Work independently on complex engineering problems, applying prior experience and technical knowledge.
• Take ownership of assigned work, effectively prioritize competing priorities, and consistently deliver high-quality results.
• Serve as a key member of cross-functional teams and build strong working relationships across the organization.
• Support multifunctional project teams through segments of the design, development, verification, validation, and product launch process.
• Demonstrate passion, energy, accountability, and a commitment to achieving business priorities.
• Collaborate effectively across functions to build partnerships and drive successful business outcomes.

• Bachelor's degree in Engineering or a related technical discipline, or equivalent combination of education and practical experience.
• Fundamental understanding of engineering practices, tools, and design principles within a regulated environment.
• Experience applying engineering concepts to product development and problem solving.
• Ability to work independently and exercise sound engineering judgment.
• Strong analytical, problem-solving, communication, and collaboration skills.
• Ability to communicate technical concepts and basic project plans effectively to team members, leaders, and project managers.

• Experience in medical device engineering, with vascular device engineering experience strongly preferred.
• Technical ability to develop and optimize medical device…