Front End Development, Project Management expertise, Market Analysis, innovative intellectual properties, good business acumen having financially impacted on product development. Plans and implements very 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: Material qualifications, Testing , Process definitions, 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: Material specifications, Quality test requirements, 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: Continuing Education, Symposia, Professional Association, Benchmarking/Comp. Assessments, Patents. Supports all development activities via application of technical expertise. Requires working knowledge of average computer/PC skills with experience in Microsoft Word, Excel, Project and PowerPoint, network systems (electronic mail) and Internet applications. Statistical based analysis program knowledge is a plus. Plans effectively and team oriented. Ability to work with little supervision. Minimum of 11-14 years previous experience as a development engineer/scientist/chemist. Previous experience with catheters, urine collection systems, and surgical products 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.
Job ID: 364