Product Development Engineer, Medical Devices

Skillcloud HCM; Greenville (PA); Presencial; USD 75.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and dental insurance

401K with company match

ESOP

Descripción de la vacante

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

The role requires mechanical or biomedical engineering expertise, ISO 13485 familiarity, and hands-on CAD capabilities, with opportunities for growth in a collaborative setting.

Formación

• Bachelor’s degree in mechanical or biomedical engineering required; an associate’s degree will be considered with demonstrated experience.
• 3–5 years’ engineering experience; medical device industry preferred.
• Strong technical writing of SOPs, work instructions, protocols.

Responsabilidades

• Maintain familiarity with ISO 13485:2016 and the Quality System.
• Initiate and contribute to ECs, CAPAs and bug reports as needed.
• Develop design input requirements and product specifications.

Conocimientos

Technical writing

Design controls

Documentation management

Problem solving

Educación

Bachelor’s degree in mechanical or biomedical engineering

Associate’s degree with relevant experience

Herramientas

CAD software

Microsoft Office 365

Descripción del empleo

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.

Skillcloud HCM Solutions has been engaged to manage this search. NO PHONE CALLS OR RECRUITERS PLEASE

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.