The Senior Product Development Engineer II will lead strategic development initiatives for the design, development, and launch of new products from concept through commercialization.

Responsible for leading design efforts required for the design and development of new products, product revisions and processes, from conception into feasibility, through launch in a timely and cost-effective manner while meeting customer requirements.

The Senior Product Development II will utilize their technical experience and project leadership to mentor the engineering team, support the implementation of product improvements, cost reductions, and product issue resolution efforts for existing product lines.

The Senior Product Development Engineer II is responsible for leading all Design Control activities required in the development of products and processes for the biopharmaceutical and fluid transfer industries assuring that all design control activities are completed in accordance with current GMP, ISO and QMS requirements.

· Design and develop products for NAI from concept to finished product following all Design Control procedures. Leading complex projects or platforms, including team members, responsible for all phases of product life cycle, including prototyping, design and development, validation and launch.

· Translate market and customer requirements into robust, manufacturable product designs.

· Manage and oversee prototyping, testing, validation, support regulatory compliance activities.

· Responsible for design plans, design documentation, design reviews, DFMEA, PFMEA, support hazard/risk mitigation strategies and all applicable verification/validation testing for the completion and release of products.

· Develop specifications, bill of materials, technical packets, Assembly Instructions and Work Instructions for projects.

· Responsible for the design, validation and implementation of the tooling and fixtures needed for the manufacture, assembly and inspection of the product.

· Responsible for the review of designs to ensure manufacturability and verify costs to meet project requirements.

· Support root cause investigations and corrective actions for design, performance, or quality issues.

· Analyze existing products to identify areas for improvement, carries out product improvement plans, update applicable design documentation including product and process validation as required.

· Collaborate with internal manufacturing partners, contract manufacturers, designers, and product specialists to optimize designs, materials and manufacturing processes for manufacturability.

· Support the stage-gate and design control process and assist in the transition as the project moves through to completion.

· Collaborate with customers, marketing, sales, manufacturing, quality and regulatory regarding new products, improvements and changes throughout the product life cycle.

· Perform feasibility studies/ROI calculations on projects to provide support for new capital improvement projects.

· Mentor and coach Level I/II engineers; review technical work and provide guidance

· Champion continuous improvement in design standards, processes, and product performance.

· Validate and qualify new equipment and/or processes ad required.

· Assist with manufacturing to resolve production issues as required.

· Submit status updates to Engineering Management.

• BS in an engineering, scientific or technical discipline or 10 years relevant work, Master’s degree or additional certifications (e.g., PMP, Six Sigma, PE license) preferred.
• Minium 8 years’ experience in product development, preferably single use systems for biopharmaceutical markets, or experience in a regulated industry.
• Proven success in leading complex design projects from concept to production.
• Strong knowledge of 3D solid modeling, quality assurance standards, and the ability to interpret mechanical drawings accurately.
• Skilled in tolerance analysis, GD&T, and design for manufacturability (DFM) principles.
• Experience designing products within a manufacturing environment with project leadership responsibility.
• Analytical skills for evaluating information carefully and solving complex problems.
• Organizational skills for keeping track of various tasks, budgets, schedules and the ability to lead project work for the team.
• Experience with cross-functional teams and project leadership.
• Excellent communication and interpersonal skills.
• Familiarity with regulatory standards (e.g., ISO, FDA, IEC) as applicable to the industry.
• Strong knowledge of manufacturing processes: injection molding, extrusion, machining, 3D printing, etc. 
• Lean Six Sigma Green Belt or Lean Green Belt
• Ability to communicate effectively, both written and verbally, with co-workers and supervisors.
• Ability to influence without authority and work effectively across organizational boundaries.
• Strong problem-solving skills and willingness to get the job done.
• High attention to detail and commitment to product quality and performance.