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.

Halkey-Roberts Corporation jobs

Senior New Product Development Engineer

Senior New Product Development Engineer