Product Engineer (m/w/d)

About pfm medical GmbH

pfm medical is a globally active mid-sized family business from Germany, specializing in high-quality healthcare products and services. Our focus is always on people—whether patients, relatives, caregivers, or employees. Our core mission is to improve therapy outcomes to enhance patients' quality of life while ensuring optimal working conditions for users in clinics, medical practices, nursing, and laboratories.

Role Overview

As a Product Engineer at pfm medical, you will take charge of development management for medical device product groups, primarily made from plastics. Your key tasks will include design management and product maintenance such as implementing design changes.

You will build and maintain technical documentation (including Device Master Records, Device History Files, test plans, and reports) to ensure compliance with regulatory standards securing product approvals.

To continuously enhance the safety and effectiveness of our products for patients, you will conduct regular risk analyses and assessments.

As the main point of contact for technical queries, you will support colleagues from production, quality assurance, regulatory affairs, marketing, and sales with expert advice.

Candidate Profile

• A completed engineering degree, preferably in plastics technology, medical technology, or related fields.
• Several years of professional experience in medical technology, particularly in medical product development and/or product life cycle management.
• Strong understanding of material properties and processing techniques for various plastics, enabling you to manage design control responsibilities effectively.
• Experience leading projects and preparing clear technical documentation compliant with European and US regulatory frameworks.
• Basic knowledge of regulatory requirements for design control and risk management for medical devices (including ISO 13485, ISO 14971, and 21 CFR 820).
• Excellent teamwork skills and fluency in both German and English to facilitate communication across sites.

Opportunities for Career Changers

If your background differs but you are eager to leverage your skills in a new field, we welcome career changers who can learn on the job with comprehensive training in Nonnweiler.

Company Values and Culture

We highly value respectful interactions characterized by openness, kindness, and patience. Enjoying working with diverse groups of people is important to thrive in our environment.

Benefits and Work Environment

• Flexibility and Trust: Benefit from flexible working hours, options for remote work, and state-of-the-art technology to self-manage your working day.
• Rest and Recreation: 30 days of annual leave standard, with options to exchange additional vacation days for salary components after two years.
• Attractive Extras: Employer-funded pension plans after three years, monthly tax-free perks such as a job bike, and asset-building benefits.
• Support in Life Situations: Receive internal support during special life circumstances including special leave and access to an external Employee Assistance Program (EAP).
• Personal & Professional Growth: Participate in targeted training and further education to expand your competencies and foster development.

Application Process and Confidentiality

Apply directly online as a Product Engineer in Nonnweiler. We ensure complete confidentiality, especially if you are currently employed. Phone interviews and meetings can be scheduled outside business hours to accommodate you.

We look forward to receiving your application and getting to know you!