Product Development Engineer- Pennsylvania

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.

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

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.

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.