Job Summary:
The Senior NPD Engineer is responsible for leading new product development activities, along with existing product evaluation and testing across multiple product lines. This position will ensure product requirements and quality standards are satisfied and to help assess how well the product will meet customer needs in terms of functionality and usability.
Duties and Responsibilities:
- Design and develop innovative products from concept to production that provide a sustained competitive advantage
- Innovation leadership to drive unique innovative solutions and processes
- Coordinate cross-functional team member activities to meet specified customer design, manufacturing, and quality requirements
- Plan, schedule, and coordinate detailed phases of engineering work
- Display originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques
- Coordinate appropriate communications with customers to facilitate requirements collection/development and project acceptance criteria
- Refine technical data received from marketing, sales, customers, and manufacturing team members
- Work with internal and external stakeholders to establish and implements strategies consistent with NPD and organizational growth objectives
- Perform evaluation testing of prototypes to prove or disprove established hypotheses
- Create appropriate project plan/documentation to adequately create a Design History File (DHF) of all projects within the guidelines of company procedures and practices
- Oversee the development and maintenance of appropriate work instructions and ISO procedures
- Develop test protocols for internal or external use; design and build test equipment; and perform design validation resulting in products that meets customer, design, and manufacturing requirements
- Lead Technical design reviews across departments. Develop technical solutions to engineering problems using analytical methods such as DOE, correlation studies, and apply statistical analysis for product improvements
- Mentor and motivate junior engineers while coaching them through activities such as FMEA’s design validation, material and components specifications
Required Knowledge, Skills and Abilities:
- Innovator: identify technological gaps and conceptualize solutions to meet market needs.
- Project management: demonstrated ability to manage phase-gate projects and accurately forecast project timelines
- Knowledge of plastic injection molding component design
- Knowledge of plastic injection molding manufacturing techniques and practices
- Knowledge of component and assembly design optimized for high volume assembly and manufacturing
- Strong organization skills: ability to multi-task and prioritize tasks to ensure deadlines are met
- Proven change agent: skill with enabling change and influencing abilities
- Mentorship: demonstrate the ability to teach advanced skills/principles to others and provide guidance to less seasoned engineers
- Rapid prototyping methods to evaluate designs
- Knowledge of patenting process
- Advanced working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPoint
- Communicate clearly and professionally with internal and external customers
- Ability to make independent decisions using available resources
- Identify and resolve problems in a timely manner, gather and analyzes information skillfully
- Open to other’s ideas and exhibits a willingness to try new things.
- Detail Oriented: demonstrate accuracy and thoroughness; monitor work to ensure quality.
Education and Experience:
- Bachelor’s Degree in mechanical engineering, biomedical engineering, or related engineering discipline
- Master’s degree or PhD preferred
- 8 - 10 years of related design and development experience in the medical device
- Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies
- Hands on experience with Design Control experience including design and process verification and validation
- Substantial experience in a Phase-Gate development process
- Significant experience in designing production equivalent rapid prototypes
- Demonstrated knowledge of applied mechanical engineering in product design and evaluation
- Strong aptitude for hands-on engineering testing and experimentation in a lab environment
- Understanding and experience in product design and development including the use of tools such as QFD, FEA, Risk Analysis, DFMEA/PFMEA, and GD&T
- Design Control experience including design and process verification and validation
- Strong design skills: proficient in 3D CAD software (SolidWorks preferred)
- Understanding of CAE tools (FEA, CFD, etc.)
- Understanding and application of ISO Quality System requirements and FDA regulations
- Excellent project management skills. Microsoft Project experience required
- Superior verbal and written communication skills
Physical Demands:
The physical demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions.
- Frequent: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboard
- Frequent: Specific vision abilities required by this job include close vision requirements due to computer work for full shift
- Seldom: Light to moderate lifting is required
- Seldom: Ability to uphold the stress of traveling
- Constant: Regular, predictable attendance is required
- Frequent: While performing the duties of this job, the employee is required to sit, stand or walk for extended periods
- Frequent: Repeatedly lift to waist level and bends to 12 inches off of floor throughout shift
- Frequent: This position requires balance, bend/stoop, climb stairs, crawl, crouch, kneel, keyboard/type, push, pull, reach, reach above shoulder, repetitive motion as well as computer/mouse use
- Frequent: Ability to wear personal protective equipment that may include some or all: safety glasses, lab coat, safety shoes, gloves, hearing protection, hair/beard covering. No make-up or nail polish permitted
Work Environment:
The work environment described is representative of what must be met by an employee successfully perform the essential functions of this job.
The physical environment is indoors in a controlled climate manufacturing setting. The noise level may moderate to loud.
Frequent use of personal protective equipment is required to prevent exposure to hazardous materials.
Frequent use of protective clothing is required to maintain clean environment.
