EMPLOYER: FHC, Inc.Website
Product Development Engineer
Job Title: Product Development Engineer
Reports To: Engineering Manager
FLSA Status: Exempt
Prepared By: MJG
Prepared Date: Nov. 2010
Revised By: Eng.Mgr (AEL)
Revised Date: Sept 2016
Approved By: HR (llm)
Approved Date: Sept 2016
SUMMARY: The Product Development Engineer with a focus on mechanical engineering will contribute to all phases of product design, development and support. Technical competencies in the areas of mechanical engineering, biomedical engineering and micro-machining are required. Specific responsibilities will vary from project to project and shall be met by performing the following duties:
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.
- Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, root cause analysis, calibration, EC’s and CAPA.
- Deliver clear and concise communication, both written and verbal, to management, other team members and end users.
- Assist team members in the development of design input requirements and product specifications.
- Provide reasonably accurate estimations of the amount of work required for completion of assigned product development tasks. Alert team members as early as possible if estimates change during the development process.
- Design novel mechanical devices based on design requirements while adhering to sound mechanical design practices.
- Review and analyze design solutions to determine suitability for manufacture.
- Maintain familiarity with the “state of the art” in machining and micromachining techniques, materials science, the biomedical industry, computer aided design solutions and mechanical engineering.
- Maintain familiarity with typical operating room procedures and usability requirements for medical equipment, apply said knowledge to designs.
- Generate procedural support documents and user manuals for developed products.
- Provide field support, installation, and training on FHC systems and products.
- Create 3D computer models of new product designs in support of engineering, production and marketing efforts.
- Oversee drafting of mechanical components to ensure proper drafting and tolerancing.
- Create verification plans and reports which leverage statistics to create dimensional confidence and tolerance intervals for new designs.
- Maintain familiarity with regulatory and safety requirements for medical and research grade equipment.
- Communicate with end users of designs to provide technical support and training, gather feedback, and troubleshoot problems. Requires willingness to work a flexible schedule with frequent extra effort when necessary.
- Create and maintain production prints, assembly instructions, bills of material, and other documentation related to developed products.
- Initiate and/or contribute to engineering changes (EC’s), corrective and preventive actions (CAPA) and bug reports.
- Develop and implement production ready processes to meet established specifications.
- Seek out continuous improvement opportunities as it relates manufacturing systems, equipment, and processes.
- Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
- Enthusiastically participate in company sponsored community events for the sake of charitable giving in the amount of 4 hours each quarter year.
Oversee technicians and drafts-persons assisting in the development process and monitor production progress on pilot production runs of new designs.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
EDUCATION and/or EXPERIENCE:
A BS degree or better in the field of Mechanical Engineering or equivalent.
English. Additional languages beneficial
MATHEMATICAL SKILLS ANND REASONING ABILITY:
Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.
CERTIFICATES, LICENSES, REGISTRATIONS:
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.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; and use of hands and fingers, handle, or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
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. The noise level in the professional, smoke-free work environment is usually moderate.