Sr. Engineer, Product

Getinge; Merrimack (NH); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge is seeking an experienced engineer to sustain production of implantable and consumable medical devices. You will lead cross-functional teams through design changes, CAPAs and NRIs, ensuring compliance with design controls and 21 CFR Part 820.

This onsite role requires a Bachelor's degree in engineering or a related field, at least five years in medical devices, and proven ability to mentor staff while navigating regulatory requirements and supplier collaborations.

Qualifications

• Demonstrated ability to lead cross-functional project teams.
• Knowledge of GDP and design controls.
• Experience with medical device regulations (21 CFR Part 820).

Responsibilities

• Leads design change projects to improve product performance and manufacturability.
• Leads CAPAs, NCRs and Product Complaints investigations.
• Leads design reviews to evaluate design adequacy and requirements.
• Supports design verification/validation protocols and feasibility studies.
• Maintains DHF and DMR throughout product lifecycle.
• Mentors junior staff and communicates project status.

Skills

Cross-functional leadership

Analytical thinking

Problem solving

Communication

Self-motivated

Agile PLM

Minitab

Education

Bachelor’s degree in Engineering or related scientific field

Tools

Microsoft Office

Job description

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.

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

• Bachelor’s degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering.
• A minimum of five years’ experience in the medical device industry (or other regulated industry) with relevant experience in design controls, production and process controls and/or R&D or related areas.
• Experience leading cross-functional project teams and being a decision-maker.
• Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
• Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.

Required Knowledge, Skills And Abilities

• Demonstrated ability to solve technical challenges with cross-functional teams.
• Strong analytical and problem-solving skills.
• Strong communication and collaboration skills.
• Self-motivated with the ability to accomplish project goals with minimal supervision.
• Experience with Agile PLM and Minitab desired.
• Knowledge of Good Documentation Practices (GDP) required.
• Excellent verbal and written communication skills.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• May work extended hours during peak business cycles.
• This position may require 5-10% travel.

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.

Annual salary of $95K to $120K depending on relevant expereince plus 10% STIP

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:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

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.