Product Development Engineer- Pennsylvania

KMA Human Resources Consulting; Greenville (PA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health & Dental Insurance

401K with company match

Employee Stock Ownership Plan

Professional development stipend

Life Insurance

HSA and DCA accounts

Job summary

FHC, Inc. is seeking a Product Development Engineer to join the Greenville, PA team for new product development and manufacturing of research and clinical devices. You will contribute to all phases of design, development and support in a multi-disciplinary environment.

The role requires mechanical or biomedical engineering expertise and hands-on involvement with design controls, verification/validation, and document management in ISO 13485 settings.

Qualifications

• Bachelor’s degree in mechanical, or biomedical engineering, or closely related field; an associate’s degree considered with experience.
• 3–5 years’ engineering experience; medical device industry preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience with Microsoft Office 365 suite.
• Demonstrated experience with CAD software.

Responsibilities

• Maintain familiarity with ISO 13485:2016 Quality System.
• Initiate engineering changes, CAPAs, and bug reports as needed.
• Develop design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions for suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, and BOMs.
• Develop production-ready processes to meet specs.
• Manage production processes to improve performance and reliability.

Skills

Mechanical engineering

Biomedical engineering

Technical writing

CAD software

Microsoft Office 365

Design controls

Education

Bachelor’s degree in mechanical engineering

Bachelor’s degree in biomedical engineering

Associate’s degree with relevant experience

Tools

CAD software

Job description

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
• 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.

FHC, Inc is an 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.