Senior Product Development Engineer

• Design and develop new products and/or line extensions and leads or supports sustaining engineering (including CAPAs).
• Create and maintain Design History File (DHF) components including design inputs/outputs, verification protocols/reports, support design validation activities, risk management files, and trace matrices.
• Develop 3D CAD models and 2D manufacturing drawings that meet product and process requirements (SolidWorks preferred).
• Performs engineering analyses, creates test methods, executes testing, to support new product development and post-market design or process changes.
• Collaborates on cross-functional teams to successfully complete assigned projects while adhering to medical device design controls/regulatory requirements.
• Fabricates prototypes with internal and external suppliers
• Works with internal and external manufacturing partners to ensure producible designs
• Effectively plan, organize, and prioritize personal tasks as well as tasks delegated to junior engineers and technicians.
• Proactively identify and communicate technical risks and mitigation strategies to cross-functional stakeholders.

• Bachelor's degree in Mechanical or Biomedical Engineering, or related field
• 5 years relevant experience in the medical industry with experience in surgical devices technology development and disposable medical devices
• Proficient with 3D CAD (SolidWorks preferred) and GD&T principles.
• Possesses engineering acumen required to support technical activities such as running engineering tests, coordinating, and generating testing protocols.
• Knowledge in analyzing and solving problems in a disciplined fashion, ensuring clear understanding of the root cause(s) and efficient recommendations for resolution
• Experience in DHF documentation and working in a regulated environment.
• Proficient in Visio and Microsoft Office Suite including Excel, Word, PowerPoint and Outlook
• Excellent communication skills, both written and verbal.
• Ability to independently lead technical assessment(s), generating, and documenting test plans and reports
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Ability to manage multiple priorities simultaneously

• Knowledge of polymer processing methods (e.g., injection molding, extrusion).
• Hands-on experience with prototype development, DFM, and collaboration with contract manufacturers or suppliers
• Experience working on cross functional project teams in the end-to-end lifecycle bringing new products/technologies from concept through commercialization
• Familiarity with statistical analysis software (Minitab preferred) and data analysis for verification/validation protocols.

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting and standing for extended periods of time.
• Bending, squatting, and lifting up to 30 lbs.
• May require travel up to 20%.

Beaver-Visitec International