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.
The Senior Project Engineer is responsible for managing new product development activities, product evaluation and testing across multiple product lines and portfolios of products. 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 Degree in mechanical engineering, biomedical engineering, or related engineering discipline.
- Master’s degree or PhD preferred
- 10 years of related design and development experience in the medical device and/or component industry.
- 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.
- Experience in a Phase-Gate development process.
- Experience in designing production equivalent 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.
- Understanding and experience in product design and development including the use of tools such as QFD, FEA, Risk Analysis, DFMA, SUS 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 Computer Aided Engineering tools (FEA, CFD, etc.)
- Understanding and application of ISO Quality System requirements and FDA regulations.
- 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.
- 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.
- Upgrade older existing products, identifying areas to streamline or improve processes and quality.
- Provide continuing product support for manufacturing, sales and quality on design requirements, customer needs, testing, CAPA, and product documentation.
- Lead the design and development of new product and product engineering and applies engineering best practices and tools. Provide leadership in design analysis.
- Coordinate with manufacturing at suitable stages during initial design to evaluate the designs and 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.
- Lead Technical design reviews across departments. Develop technical solutions to engineering problems using analytical methods such as Design of experiments, optimizing product design, correlation studies, and apply statistical analysis for product improvements.
- Apply FMEA process to implement sound engineering solutions.
- Mentor and motivate junior engineers while coaching them through activities such as FMEA’s design validation, material and components specifications.
- Develop test plans, adjust design, run performance calculations, maintain 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.
- Operate in a LEAN manufacturing environment and strive to suggest process improvements
An Equal Opportunity Employer
Job Type: Full-time
Pay: $112,000.00 - $118,000.00 per year
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Vision insurance
Ability to commute/relocate:
- Saint Petersburg, FL 33716: Reliably commute or planning to relocate before starting work (Required)
- Product Development: 8 years (Preferred)
- Design Control: 8 years (Preferred)
- Phase-Gate development process: 8 years (Preferred)
- SolidWorks: 4 years (Preferred)
- Medical Device Industry: 6 years (Preferred)
- rapid prototyping: 6 years (Preferred)
- Plastics injection molding: 6 years (Preferred)
Work Location: In person