Job Description

Job Title: Sr Product Design Engineer

Pay:  $80-105/hr (Depending on years of experience) 

Benefits: Eligible to Enroll in Medical Benefits

Job Overview: This role will report through senior management and is responsible for the direct leadership of product engineering design in developing and optimizing oral care medical devices in alignment with the US FDA 21CFR 820 Medical Device Design Control requirements and ISO13485. Full lifecycle support includes ability to navigate both in-house and contract manufacturing environments of Class I and II medical devices and product packaging.

Job Functions:

• Work closely with cross functional team and guide engineering team through adherence to design control process through the creation of design inputs, design outputs, design verification and validation protocols/reports and the support of design transfer to manufacturing in alignment with timelines.

• Ensure all products are designed and manufactured in compliance with FDA regulations and industry standards. Participate in design reviews and risk assessments.

• Lead and mentor a team of product engineers, fostering a collaborative and innovative work environment. Provide guidance on technical challenges. Promote industry best practices to enhance efficiency, quality, and innovation.

• Independently coordinate, compile, and manage device drawings and specifications within an electronic document control system and work with design team to generate quality product.

• Support sustaining design control system through the assessment of post market design change and completion of required deliverables to implement the change. 

• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

Requirements:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field)

• Minimum of 10 years of Project Development Engineering experience in the Medical Devices industry with Class I and II Medical Devices.

• Strong understanding of FDA regulations and ISO standards related to medical devices.

• Experience with US FDA Unique Device Identification requirements is desirable.

• Statistical software and sample plan creation experience for protocols is desirable.

• Leadership skills are required for this position

• Excellent written and verbal communication skills

• Proficiency in AutoCad software and MS Office applications including Word, Excel, PowerPoint

• Good interpersonal and organizational skills

Pinpoint Pharma is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.