The Product Development Manager is responsible for new product development of energy based surgical devices. This is a key role in the R&D department, providing design and development expertise and technical leadership to the team throughout the entire product lifecycle. The position requires a team-oriented individual with strong engineering, organizational and interpersonal skills and the ability to pass those skills to less experienced engineers.
Essential Job Functions:
- Serve as a lead engineer and project manager for development of innovative surgical devices.
- Technical leadership position that includes developing and mentoring engineers and technicians on the R&D team. This position will have direct reports.
- Project Management of intermediate to large development projects or programs.
- Develop aggressive but realistic project timelines
- Drive results through building relationships and strong technical decision making.
- Lead product development through various stages of prototyping to final design by applying sound and good engineering principles including product requirements, concept design, concept selection, prototyping, testing, pre-clinical evaluation etc.
- Work directly with clinicians to review product performance. Define and understand customer requirements and translate those requirements into product designs.
- Design high-precision machined and plastic injection molded components.
- Design complex components and assemblies capable of achieving overall device requirements.
- Evaluate and apply design tradeoffs and constraints for design optimization
- Ensure product design robustness through appropriate testing.
- Apply DFSS, DFA, DFM, Design for Lean and other fundamental engineering principles.
- Perform design verification, design validation and usability validation.
- Accountable for product design and performance throughout the entire product lifecycle.
- Present status of plans and projects to company management
- Network with senior internal and external personnel to facilitate cross-functional teamwork
- Ensure that development work follows established design control processes
- Develop strong product knowledge to provide technical expertise to other functional areas.
- Interface with customers and suppliers
- Improve processes, always looking for more efficient and effective ways of achieving results.
- BS degree in Engineering (Mechanical, Biomedical) or other relevant technical/scientific discipline required.
- A minimum of 8+ years of experience (with progressively increasing responsibility) is required.
- Previous medical device product development experiencerequired (preferably from electrosurgery or other energy based surgical devices)
- Previous experience in a highly regulated environment for Class II medical devicesrequired (preferably single-use disposable devices)
- Comprehensive experience and strong track record in product design and development
- Experience in managing development projects with tight timelines
- Ability to train and coach other engineers
- Proficient in CAD, tolerance stack-ups and drawing reviews. Knowledge of GD&T
- Experience with Finite Element Analysis and other tools for engineering analysis
- Good understanding of plastic component design, injection molding and extrusion
- Experience with a variety of manufacturing processes, for example machining, molding, joining, forming, additive manufacturing
- Material selection based on analysis of mechanical, electrical and thermal properties
- Understanding of DFSS, DFM and Design for Lean activities in early phases of product design
- Experience from working with clinicians for development of new products including translating user needs to engineering requirements and design
- Executing pre-clinical and/or cadaver labs for evaluation of prototypes and new designs
- Working knowledge of DFMEA and other risk assessment tools
- Design verification and validation protocol and report writing
- Understanding of Lean principles, Six Sigma and their implementation
- Working knowledge of statistical tools such as DOE, Statistical Process Control, Hypothesis Testing and Process Capability Studies
- Experience from working with vendors.
- Ability to identify and resolve issues without direct supervision
- Demonstrated problem solving skills
- History of successfully transferring designs to manufacturing
- Excellent organizational skills and attention to detail
- Ability to effectively handle conflict through proactive action and direct and timely communication
- Excellent time management skills
- Good verbal and written communication skills
- Leadership and self-starter qualities
- Ability to prioritize workload, meet multiple deadlines simultaneously in a fast-paced environment
QUALITY ASSURANCE RESPONSIBILITIES: The individual must comply with the following quality system requirements including but not limited to:
- 1. Use only formally approved procedures, records, documents and specifications known as "Control Documents" (e.g., device history records, data collection forms, drawings, procedures, and specifications).
- 2. Use only properly calibrated and maintained equipment.
- 3. Immediately bring to attention of the head of the Quality Assurance Department any possible deviations from specified Standard Operating Procedures or Work Instructions he or she may notice.
- 4. Ensure no components, parts, manufacturing materials or products will be released unless they meet all inspection and test criteria.
- 5. Follow all Standard Operating Procedures and Work Instructions relating to the functions preformed.
LANGUAGE SKILLS: Ability to read, analyze and interpret common scientific and technical journals, financialreports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to personnel of all levels from top management, public groups, and/or boards of directors to introductory level employees.
MATHEMATICAL SKILLS: Ability to adapt advances mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis or variance, correlation techniques, sampling theory, and factory analysis.
REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and risk of electric shock. The noise level in the work environment is usually moderate.No Sponsorship.No State Income Tax.