Product Development Engineer – Pennsylvania

FHC Company; Greenville, Northern (PA, KY); Hybrid; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health, Dental Insurance options

401K with company match

Employee Stock Ownership Plan

Generous PTO, holiday pay, paid sick时间

Professional development support up to

Job summary

FHC, Inc is seeking a Product Development Engineer to join our Greenville, PA site and contribute to multi-disciplinary development and manufacturing of research and clinical devices.

The role focuses on new product development, design input, and ensuring design controls are implemented throughout the product lifecycle, working within ISO 13485:2016 guidelines and a collaborative team environment.

Qualifications

• Bachelor’s degree in mechanical, or biomedical engineering, or closely related field; an associate’s degree will be considered with demonstrated experience.
• 3-5 years’ experience in engineering; medical device industry experience preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience working with CAD software.
• Demonstrated understanding of ISO 13485:2016 and related regulations.
• Experience working with engineering drawings.
• Hands-on experience with design controls, design verification/validation, design and development file management.

Responsibilities

• Maintain familiarity with FHC Quality System per ISO 13485:2016.
• Initiate/contribute to engineering changes (ECs), corrective and preventative actions (CAPAs) and bug reports as necessary.
• Contribute to development of design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions to determine suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, bills of material.
• Develop production ready processes to meet established specifications.
• Manage production processes to maintain and improve performance and reliability.

Skills

Technical writing

Documentation experience

Engineering design understanding

Education

Bachelor’s degree in mechanical or biomedical engineering

Associate’s degree with demonstrated experience

Tools

CAD software

MS Office 365

Job description

FHC, Inc

Product Development Engineer

Greenville, Pennsylvania

FHC, Inc is searching for a Product Development Engineer to be based on site at their Greenville, PA location. FHC, Inc. has served the neuroscience community for over 50 years. With a guiding principle of innovation through collaboration, FHC designs, manufactures, and internationally markets products that provide customizable, pioneering solutions for neuroscientists, neurologists, and neurosurgeons.

Job Summary:

The Product Development Engineer will work in a multi-disciplinary environment with a focus on new product development and manufacturing of research and clinical devices. The engineer contributes to all phases of product design, development, and support. Technical competencies in the areas of mechanical or biomedical engineering are required.

What We Offer:

• Salary in the range of $75-85K
• Health, Dental Insurance options
• 401K with company match
• Employee Stock Ownership Plan
• Generous PTO, holiday pay, paid sick time
• Up to $1000/ year for approved professional development
• Options for Life Insurance, HSA and DCA Accounts
• Positive, collaborative, team focused work environment
• Convenient Greenville, PA location

Qualifications:

• Bachelor’s degree in mechanical, or biomedical engineering, or closely related field required; an associate’s degree will be considered with demonstrated experience.
• 3-5 years’ experience in engineering; medical device industry experience preferred.
• Excellent technical writing of controlled documents (SOPs, work instructions, protocols).
• Experience working within the Microsoft Office 365 suite
• Demonstrated experience working with CAD software.
• Demonstrated understanding of ISO 13485:2016 and related regulations.
• Experience working with engineering drawings.
• Hands-on experience with design controls, design verification/validation, design and development file management.

Responsibilities:

• Maintain familiarity with FHC Quality System per ISO 13485:2016.
• Initiate/contribute to engineering changes (ECs), corrective and preventative actions (CAPAs) and bug reports as necessary.
• Contribute to development of design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions to determine suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, bills of material.
• Develop production ready processes to meet established specifications.
• Manage production processes to maintain and improve performance and reliability.

Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.