What are the responsibilities and job description for the Sr Engineer, Product - Merrimack, NH position at Atrium Medical Corporation?
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.
Onsite Role
Job Overview
This position delivers engineering solutions to sustain production of implantable and consumable medical devices. Responsibilities include leading 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
- Leads design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
- Leads CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
- Leads Design Reviews at appropriate stages 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.
- Successfully leads project teams by identifying and mitigating project risks and tracking all project deliverables to completion.
- Provides technical expertise throughout the supplier selection and evaluation process.
- Mentors junior-level staff members.
- Provides updates to management on project status.
- Supports internal and external audits.
- Contributes to the team effort by accomplishing related tasks as needed.
Minimum Requirements
Required Knowledge, Skills and Abilities
Environmental / Safety / Physical Work Conditions
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
95,000 - 120,000 annually 10% STIP
LI-YA2
LI-Onsite
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.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
