Development Engineer II - Sustaining

Responsibilities:

• Executes sustaining projects with limited supervision.
• Authors and releases ECOs; ensures compliance.
• Participates in root cause and CAPA execution.
• Supports cost reduction and supplier change initiatives.
• Identifies incremental product/process improvements.
• Contributes to standardization of sustaining documentation.

Requirements:

• Demonstrated good written and verbal communication skills, including presentation skills required.
• Knowledge of ASME GD& T standards with application to product design desired.
• Knowledge of various manufacturing processes (including subtractive machining, anodization, additive manufacturing, forging, casting, and plastic molding) and material science for application in new product development desired.
• FDA QSR and EU MDR medical device regulatory requirements and industry/regulatory body-recognized technical product standards knowledge desired
• Statistics knowledge with application to sample size determination and null hypothesis testing desired.
• Microsoft Office Suite software proficiency required.
• Demonstrated product design and development execution with a multidisciplinary project team from user need identification/concept ideation through commercialization desired; medical device, particularly orthopedic implant, and instrument product design desired.
• Bachelor's degree in engineering or a relevant degree and 2+ years of relevant experience.

Preferred:

• Minimum B. S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Mechatronics Engineering, Aerospace Engineering, or Aeronautical Engineering.
• 2 to 5 years of full-time (including relevant Zimmer Biomet/B Coop/Intern) engineering experience.

Expectations:

• Solid engineering analysis and problem-solving to support sustaining tasks.
• Competent in drafting, authoring, and releasing compliant ECOs.
• Ability to participate in CAPA/root-cause investigations.
• Familiarity with cost reduction, supplier changes, and process improvements.
• Effective communication with cross-functional partners.
• Ability to organize documentation and standardize sustaining practices.

Skills

CAPA, ECO, GD&T, corrective action, engineering change order, geometric dimensioning, tolerancing