Staff Engineer, R&D - Sustaining

What you will do

As the Staff Engineer, R&D - Sustaining, you will ensure commercialized products or technologies meet performance, safety, compliance, and cost targets by assessing and driving design changes and supporting global commercialization activities. Changes may include working with suppliers or manufacturers on material changes, compliance to new test standards, product performance improvements, new test methods, process improvements, product line extensions, and supporting manufacturing transfers.

• Assesses testing required and patient risk for design changes and will manage the execution.

• Takes initiative to reach out to internal NV expertise (team, function, division) or consultants to resolve technical issues.

• Applies in-depth knowledge of customer needs, market, and competitive offerings.

• Applies detailed knowledge of clinical procedures to author design inputs.

• Supports Voice of Customer sessions internally and with clinicians.

• Interfaces with physicians or Cath Lab personnel to obtain feedback on performance of devices.

• Oversees product testing for design verification, design validation, shelf life, engineering studies and equivalency. Drafts protocols and reports as needed.

• Supports Regulatory filings by providing expert technical input and responding to questions from Regulatory agencies.

• Builds Quality into all aspects of their work by maintaining compliance to all quality requirements. Generates and authors quality documents.

• Coordinates cross-functionally to execute and implement design changes with Regulatory, Quality Assurance, internal or external Manufacturing, and Supply Chain.

• Works with some latitude for independent action or decision. Self-manages time, completes most tasks with minimal guidance. Influences design decisions.

• Identifies and supports the creation of or improvements to procedures, policies, processes, systems, and technology.

• Trains and/or provides work direction to technicians and less experienced engineers.

• Supports engineering teams to the successful completion of project goals.

• Demonstrates knowledge of internal product and/or technology development processes through coaching and delivery of high quality, high impact deliverables.

What you need

• B.S. degree in engineering or applicable technical field.

• 4+ Years of related experience.

• Prior experience in medical device industry preferred.

• Excellent interpersonal and communication skills with good leadership abilities.

• Ability to understand, analyze, and troubleshoot complex systems.

• Ability to lead structured problem-solving initiatives to resolve complex technical issues.

• Ability to interface with physician customers, understand relevant procedures, and interpret customer needs and product requirements.

• Experience in Sustaining, Product, Quality or Manufacturing Engineering preferred.

• Experience applying knowledge of materials and manufacturing processes to product design preferred.

• Knowledge of R&D, Design Control, Process Improvement, Quality Engineering, Project Management

• Knowledge of Six Sigma or other Problem-Solving methodologies preferred.

• Knowledge of engineering drawings, models and applying GD&T and CAE tools

The successful candidate will have a HIGH LEVEL of Responsibility and Commitment. Will be Execution and Results-Driven and have a mindset to Sustain commercial products.