Product development engineer serp_jobs.h1.location_city

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

This position delivers engineering solutions to sustain production of implantable and consumable medical devices. Responsibilities include working with cross-functional teams to support design and supplier changes, CAPAs, NCRs, Product Complaints and other compliance projects. This job requires knowledge of medical device regulations including design controls.

Job Responsibilities and Essential Duties

• Initiates design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
• Works with current suppliers on changes to existing purchased components and with new prospective suppliers.
• Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
• Participates in Design Reviews to evaluate adequacy of design requirements, assess the capability of the design to meet requirements and identify and resolve problems.
• Works cross-functionally on design changes, process improvement projects and quality / compliance initiatives.
• Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
• Aids in the selection, design and evaluation of process and test equipment.
• Creates and executes protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
• Processes change orders to create or revise design input and output documentation.
• Performs product testing and engineering studies to support design change and investigational activities.
• Performs Out of Specification (OOS) investigation reports for test failures.
• Supports Out of Tolerance (OOT) investigations for equipment calibration failures.
• Supports the development and revision of part specifications and other design documentation.
• Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
• Periodically provides updates to project teams and program managers.
• Contributes to the team effort by accomplishing related tasks as needed.

Minimum Requirements

Required Knowledge, Skills and Abilities

Supervision / Management Of Others :

Internal and External Contacts / Relationships

Environmental / Safety / Physical Work Conditions

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge :

At Getinge, we offer a comprehensive benefits package, which includes :

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.