Sr. Development Engineer

Description

JOB SUMMARY STATEMENT

This position has the responsibility to execute development activities of various complexities for medical devices. These devices include electro‑mechanical systems and related disposable mechanical products and accessories. The individual in this role will be involved with developing new products, enhancing existing products, and implementing compliance improvements. This position partners with Marketing, Quality, Regulatory, Clinical and Operations and is critical to the success of Nuwellis’ business strategy.

• Technical expert on cross‑functional development projects.
• Execute tasks, often of at least moderate complexity, as assigned by the project manager throughout all development phases and in accordance with all applicable procedures, regulations, and standards.
• Perform tasks which directly impact milestone and project completion.
• Evaluate product qualification activities and risk management documentation against released standards and best practices. Close gaps as appropriate.
• Generate new product development concepts and prototypes for existing product enhancements as well as new product designs.
• Develop and execute product verification and validation activities.
• Review, initiate, and/or approve change requests associated with: design verification & validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
• Partner with, and occasionally lead, other functional areas in preparing test plans, data analysis, specifications, risk analysis, and change implementation.
• Demonstrate expertise with electro‑mechanical systems and related disposables.
• Capacity to interpret and contribute to electro‑mechanical systems and related disposables.
• Participate and lead challenging team discussions resulting in robust decisions with respect to product development plans.
• Facilitate effective communications with project team, support team and management.
• Manage project execution to achieve project plan/contract. Proactively address issues to minimize their impact to project.
• Provide project updates with management in a professional and unbiased manner.
• Frequently take on responsibility to manage development projects involving other cross‑functional members.
• Effectively engage with external suppliers as required by the project.
• Provides mentorship for more junior members of the technical team.

• Bachelor’s degree in related field such as Mechanical, preferably Electrical engineering.
• 5 years of experience in medical device development and quality systems.

• Graduate degree in related field such as Mechanical, Electrical Engineering.
• Experience in biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards.
• Excellent writing and verbal communication skills.
• Ability to influence others.
• Strong analytical and problem‑solving skills.
• Demonstrated decision making skills.
• Good interpersonal skills.
• Ability to handle multiple tasks/projects and manage priorities accordingly.
• Ability to manage through ambiguity.

• Mid‑Senior level

• Full‑time

• Engineering and Information Technology

• Medical Equipment Manufacturing