Senior Development Quality Engineer

As a Senior Engineer, you will be providing development and sustaining support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls with a focus in the disposable catheter. You will be a key contributor to the design, development and testing activities for complex medical devices.

Who we want

• Critical thinkers: People who challenge status quo and work to find just the right solutions.
• Collaborators: Partners who listen to ideas, share thoughts, and work together to move the business forward.
• Problem Solvers: People who can take on complex problems and apply first principles and sound technical practices.
• Communicators: People who can communicate project progress, data analysis and conclusions effectively across a broad set of stakeholders.
• Responsible: People who own their deliverables and activities and see things through to completion. People who take personal accountability for end results.

What you'll do

• Be a core team member to implement complex development projects including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Train and develop other lower-level engineers.
• Execute on Holistic & Strategic Design Verification/Validation Strategies with emphasis on: Technical analysis of requirements, specifications, and control strategy; Efficient and cost-effective execution of validation and verification; Alignment of design outputs to production and process controls; Proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects.
• Influence design and verification decisions through use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
• Serve as a front-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

• Bachelor level degree in Engineering or Technical Field
• Minimum of 6 years engineering experience with new product development
• Working knowledge on design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to collaborate on-site on a regular basis.
• Ability to travel approximately 10%, including internationally.
• Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971
• Prior medical device experience preferred.