Product Development Engineer - Remote

Overview

Responsible for leading all phases of the product development process in support of immediate, mid-term, and long-term innovation and product design strategies.

In Short

• Lead product development process for innovation and design strategies.
• Manage design control process and coordinate verification and validation activities.
• Conduct risk assessments and resolve product failures.
• Work with manufacturers to implement corrective actions.
• Identify product opportunities and establish business cases.
• Oversee product development timelines and corporate priorities.
• Generate product designs and technical specifications.
• Evaluate prototypes for usability and quality.
• Work with legal on intellectual property protection.
• Generate necessary protocols and technical documentation.

Requirements

• Bachelor’s degree in Engineering or Science.
• At least 2 years of product development experience.
• Experience with medical device requirements and design controls.
• Knowledge of 21 CFR Part 11 and 21 CFR Part 820.
• Project management experience and Microsoft Project skills.
• Experience with Minitab for test data analysis.
• Familiarity with CAD systems, preferably Solid Works.
• Knowledge of Six Sigma and high volume manufacturing processes.

Benefits

• Competitive total rewards package.
• Continuing education and training opportunities.
• Health insurance and life/disability coverage.
• 401(k) contributions.
• Paid time off.