• Plans and implements complex business oriented needs.
• Coordinates the pipeline initiatives for area identified. Works with team leaders and team members to ensure pipeline initiatives are satisfied. Matrix responsibility for core team members and support team members.
• Sets the standard for other Engineers and provides leadership and direction for the growth and improvement of the department and the company.
• Provides guidance, advice, and support to Engineers and Technicians in areas of: project leadership, technical consultation, documentation, quality, GMP procedures, Engineering disciplines, interfaces with other functions, and company policy.
• Represents product design, fitness for use, safety, and efficacy, and quality definition considerations to Engineers and Technicians.
• Designs and develops innovative and/or low cost products/systems to support both short and long term business plans.
• Concepts prototype devices utilizing innovative material and process technologies to achieve concept objectives.
• Conducts design reviews and performs failure mode and effects analysis.
• Leads multi-functional product development teams by coordinating/delegating technical and administrative responsibilities, identifying critical action items and obtaining closure, and following corporate product development guidelines.
• Reviews new product concepts; and in conjunction with a product development team, develops design requirements and project schedules. 
  • Develops laboratory tests and protocols to assure conformance of prototype devices to performance specifications, FDA regulatory and biocompatibility requirements.
  • Interfaces with Manufacturing for the fabrication of devices to support both animal and human clinical evaluation to include:
  • 1. Material qualifications
  • 2. Testing
  • 3. Process definitions
  • 4. Documentation
  • Evaluates device performance through animal and/or human clinical investigation; and, as required, implements appropriate product changes to include revision of performance specifications.
  • Transfers new products/systems to Manufacturing to include:
  • 1. Material specifications
  • 2. Quality test requirements
  • 3. Technical instruction
  • Interfaces with vendors, consultants, and customers.
  • Provides technical direction to manufacturing during pilot production, as well as on currently manufactured products.
  • Communicates project status, through verbal and written reports and schedules, to management.
  • Maintains accurate and timely records of the development of products according to laboratory notebook protocols.
  • Hires, trains and coaches Team Leaders, Engineers, and Technicians to thrive in a results-driven environment. Implements performance management duties including performance appraisals and salary reviews.
  • Maintains a current status field of expertise through:
  • 1. Continuing Education
  • 2. Symposia
  • 3. Professional Association
  • 4. Benchmarking/Comp. Assessments
  • 5. Patents
  • Supports all development activities via application of technical expertise.

LANGUAGE SKILLS

Good oral and written communication.  Ability to read, analyze, and interpret professional/technical journals, scientific literature, procedures, and governmental regulations.  Ability to write routine reports and business correspondence.  Ability to communicate well with individuals at all levels of the organization.

MATHEMATICAL SKILLS

Ability to perform basic engineering calculations.  Well versed in design of experiments.  Understanding of statistical concepts.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of concrete variables where only limited standardization exists.

This position requires good judgment.  All activities are to be carried out according to applicable laws and regulations.   When in doubt, the incumbent should source out the appropriate information via internal and external resources.

• Minimum of 11-14 years previous experience as a development engineer/scientist/chemist.
• Previous experience with catheters in the realm of Urology and Critical Care preferred.
• Prefer knowledge of Mechanical, Plastics, Chemical or Biomedical Engineering normally attained through a minimum of a 4-year technical degree. Advanced degree in business or equivalent experience is needed.
• Previous experience as a Sr. Project Engineer.
• Previous experience in directing the activities of lesser experienced Engineers and Technicians.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear.  The employee is frequently required to use hands to handle and feel.  The employee must be able to lift or move boxes of product/raw materials.  Specific vision abilities required by this job.

No special work environment conditions other than exposure to chemicals and high heat in a laboratory setting.