Senior Product Development Engineer

Purpose

The Senior Product Development Engineer is responsible for leading and participating in high impact Research & Development initiatives, including new product development and line extensions, and sustaining activities in support of business objectives. In addition, the Engineer is responsible for supporting product development activities including design control documentation and testing

Key Responsibilities

• 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.
  
  

Qualification

Required Qualifications

• 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
  
  

PREFERRED SKILLS

• 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.
  
  

PHYSICAL REQUIREMENTS

• 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%.
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com