Halkey-Roberts has been a successful business for 80 years now. We provide innovative, cost efficient, quality components to the OEM market for a range of products for specific niche markets. This includes for the health care field, inflator systems, and pressure relief valves. Our company culture is diverse and the average tenure for our employee population is 10+ years. If you are looking for a stable and successful company, Halkey-Roberts is the place to be.

Summary:

The (R&D) Project Engineer II is responsible for managing new product development activities, along with existing product evaluation and testing. 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.

Education / Experience:

• Bachelor’s Degree in Mechanical Engineering, Biomedical, or other related Engineering discipline.
• 5 years of design and development experience in the medical device and/or component industry (college internship experience considered).
• Design Control experience including design and process verification and validation.
• Understanding and experience in product design and development including the use of tools such as FEA, Risk Analysis, DFMA, SUS and GD&T.
• Experience in producing rapid prototypes.
• Knowledge of statistical methods/analysis, experience with application of Six Sigma statistical analysis, and controls
• Demonstrated knowledge of applied mechanical engineering in product design and evaluation.
• Strong aptitude for hands-on engineering testing and experimentation in a lab environment.
• Proficient in 3D CAD software (SolidWorks preferred).
• Understanding of CAE tools (FEA, CFD, etc.)
• Excellent project management skills. Microsoft Project experience preferred.
• Superior verbal and written communication skills

Required Knowledge, Skills, & Abilities:

• Solid working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPoint
• Communicate clearly and professionally with internal and external customers
• Work effectively as part of a team to achieve established outcomes. Understand other’s roles and empower one another to take responsibility to be successful. Demonstrate a collaborative interaction with peers to reach a common goal.
• Pay close attention to detail in all aspects of the job
• Make decisions using available resources and sound judgment
• Maintain confidentiality and discretion
• Identify and resolve problems in a timely manner, gather and analyzes information skillfully
• Effectively teach, coach, and counsel associates by effectively communicating and providing follow-up.
• Open to other’s ideas and exhibits a willingness to try new things.
• Demonstrate accuracy and thoroughness; monitor work to ensure quality.
• Prioritize and plan work activities to use time efficiently.
• Adapt to changes in the work environment, manage competing demands and is able to deal with frequent change, delays, or unexpected events.
• Follows instructions, responds to direction, and solicits feedback to improve.
• Act in such a way to instill trust from management, other associates, as well as customers.

Responsibilities:

• Design and develop new products for in-house production and other manufacturing sites within the corporate group.
• Perform research and testing on product concepts, new, and existing products. Conduct material, design and process changes to existing products by following design control processes and analyses of defects. Identify areas to streamline or improve cycle time and quality.
• Provide continuing product support for manufacturing, sales and quality on design requirements, customer needs, testing, CAPA, and product documentation.
• Coordinate with manufacturing at suitable stages such as at initial design to evaluate the designs ability to optimize for manufacturing in an efficient and economical manner.
• Ensure compliance to the requirements of ISO13485 standards, FDA regulations, and Good Manufacturing Processes regarding process, design, and development of new and existing product through communication and training.
• Collect and analyze data and present test results to the engineering team.
• Generate and review engineering change orders.
• 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.
• Apply FMEA process to implement sound engineering solutions.
• Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards, and approve prototypes.
• Develop product literature by recording, interpreting and explaining technical data and product performance.
• Responsible for product project management from prototype to full production based upon accurate project schedules and budgets.
• Design detailed project plans with engineering, manufacturing, and sales / marketing teams to manage all aspects of product development and production.
• Demonstrate strong drive for results and accountability for successful and timely completion of tasks and projects.
• Operate in a LEAN manufacturing environment and strive to suggest process improvements

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.

• Constant: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboard
• Constant: 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 manufacturing setting. The noise level may be 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

Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 10+ years
• 401k with employee matching available
• Paid vacation and other excellent benefits

An Equal Opportunity Employer

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Design & Development: 4 years (Required)
• Medical Device Industry: 4 years (Preferred)
• Design Control: 3 years (Preferred)
• Rapid Prototyping: 3 years (Preferred)
• SolidWorks: 3 years (Required)
• Project Management: 3 years (Preferred)
• Microsoft Project: 2 years (Preferred)

Work Location: One location

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