Staff Engineer

Essential Duties and Responsibilities

• Provides Technical Leadership for New Product Development projects
• Directly responsible for leading urgent and/or important projects from the planning and administration of the product through all development, laboratory test, clinical evaluation, and market preference test.
• Invent/Innovate prototype devices utilizing innovative material and process technologies to achieve concept objectives. Conduct design reviews and perform failure mode and effects analysis.
• Be able to work independently applying comprehensive and diverse engineering principles and practices to broad assignments, possibly including independently leading a moderate project, under the direction of Technical Management.
• Review new product concepts; and in conjunction with a product development team, develop performance specification and project schedules.
• Create 3-D CAD databases.
• Closely follow established design control procedures and documentation practices.
• Aid in ensuring the Quality System Requirement (QSR) compliance of design control process in product development.
• Develop laboratory tests, protocols and reports to assure conformance of prototype devices to performance specifications, FDA and applicable international regulatory and biocompatibility requirements.
• Interface with internal and external engineering groups for the fabrication of devices to support both animal and human clinical evaluation.
• Evaluate device performance through animal and/or human clinical investigation; and, as required, implement appropriate product changes to include revision of performance specifications.
• Transfer new products/systems to Manufacturing
• Interface with vendors, consultants, and customers. Provide guidance on the development of supply agreements as required.
• Provide technical direction to manufacturing during pilot production, as well as on currently manufactured products.
• Communicate project status, through verbal and written reports and schedules, to management.

Qualifications

• Proven experience in technology or innovative product development preferably in the medical device industry with successful track record of commercializing Class 1, 2, products
• Experience in Urology, Surgical, Wound Care preferred.
• Proven ability to interface with various levels of the organization.
• Requires solid understanding of:
• Industry regulations as it pertains to medical devices
• External Standards, Design controls, Quality controls, Manufacturing methods
• Requires track record of:
• Development and commercialization of medical devices
• Generating and documenting intellectual property
• In depth or creative approach to problem solving
• Contributes to development of new concepts
• Technical guidance on design theories and applications
• Capable of prioritizing tasks and provide a timely schedule of completion.
• Capable of detailed component and sub-assembly level analysis (not limited to tolerance or finite element analysis)
• Capable of performing complex analysis independently
• Demonstrated proficiencies of communicating best practices
• Protocol/report testing and writing (Verification and Validation)
• Test method validation
• Human Factors Engineering (Formative and/or Summative)

Education and/or Experience

• 6-8+ years of experience as a design / development engineer.
• Minimum of a 4-year technical degree in Mechanical Engineering.
• MS, MBA, or PhD preferred

Computer Skills

• Full working knowledge of Microsoft Office Suite programs and various statistical software packages.
• Good Internet skills, including ability to perform searches for specific information and all information on a specific topic, etc.

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.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• 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.