Senior Engineer R&D - Codes and Standards

Apply Now

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Courage
Action Oriented
Collaborates
Cultivates Innovation
Manages Ambiguity
Drives Results

Senior Engineer R&D - Codes and Standards

Apply Now

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Currently we are looking for a Senior Engineer R&D specialised in codes and standards who will join our team in Luleå, Sweden. As a part of an R&D project team, the Senior Engineer Codes and Standards (C&S) leads the execution of C&S deliverables for new product development and for sustaining existing products through the products lifecycle. The C&S engineer provides expertise helping ensure the product designs are developed, maintained, and verified in compliance with the applicable codes and standards.

What you'll be doing

· Identify and document the standards that a product needs to meet based on understanding C&S and Regulatory implications of proposed design solution to meet compliance requirements of domestic and relevant foreign regulatory agencies.

· Document C&S plan for meeting compliance standards that are identified in the Design Requirement Specification including C&S verification.

· Lead the successful execution of the C&S plan for the product/projects.

· Provide documentation supporting applicable European Directive Compliance and technical file for CE marking.

· Document the certifications of the sites that will manufacture the product, including sub-contractors.

· Document the device and/or accessories compliance with the Essential Requirements defined in MDD Annex I or General Safety and Performance Requirements in MDR Annex I. Included within the Technical File.

· Lead interface for safety agency certificates & approval, documenting product certification by a third party review conducted by a recognized body.

· Lead interface for CB Report and Certificate, documenting product certification by a third party review conducted by a recognized body into a international report style.

· Lead EU Certification using appropriate MDD/MDR Annex path, documenting the product's compliance to the MDD 93/42/EEC or EUMDR 2017/745/EU for the European market. This is a third party review of the Technical File by a recognized body.

· Collaborate with cross functional teams, including engineering, quality, internal and external labs, and regulatory affairs, to ensure that products meet or exceed industry standards and regulations

What you'll bring

· BS or MS in an applicable engineering discipline with 3 or more years of experience in the design and implementation of complex systems.

· Experience in compliance engineering on complex design projects utilizing formal standards testing methodologies.

· Experience in Requirements and Risk Management, Configuration Management, Issue Management and Traceability.

· Good hardware interfacing background and system integration experience with microprocessor hardware and software.

· Experience in resolving complex technical problems in collaboration with design engineers.

· Demonstrated experience interfacing with certification bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).

· Demonstrated leadership competency working with diverse teams to solve complex problems.

· Demonstrated experience working with product standards and their global variants

· Knowledge of EMC regulations and certification procedures applicable to Electromechanical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).

· Knowledge of lEC based safety standards, preferred: IEC/EN/UL 60601-1, lEC 60601-11, ISO10535, and EN 60601-2-52

· Able to work on multiple, competing priorities and resolve conflicts when necessary.

- Fluent English (Fluent Swedish is a plus)

Bachelor's Degree (±16 years) - Engineering, English, Identify and document the standards that a product needs to meet based on understanding C&S and Regulatory implications of proposed design solution to meet compliance requirements of domestic and relevant foreign regulatory agencies.
Document C&S plan for meeting compliance standards that are identified in the Design Requirement Specification including C&S verification.
Lead the successful execution of the C&S plan for the product/projects.
Provide documentation supporting applicable European Directive Compliance and technical file for CE marking.
Document the certifications of the sites that will manufacture the product, including sub-contractors.
Document the device and/or accessories compliance with the Essential Requirements defined in MDD Annex I or General Safety and Performance Requirements in MDR Annex I. Included within the Technical File.
Lead interface for safety agency certificates & approval, documenting product certification by a third party review conducted by a recognized body.
Lead interface for CB Report and Certificate, documenting product certification by a third party review conducted by a recognized body into a international report style.
Lead EU Certification using appropriate MDD/MDR Annex path, documenting the product's compliance to the MDD 93/42/EEC or EUMDR 2017/745/EU for the European market. This is a third party review of the Technical File by a recognized body.
Collaborate with cross functional teams, including engineering, quality, internal and external labs, and regulatory affairs, to ensure that products meet or exceed industry standards and regulations.
Collaborate with external stakeholders, such as regulatory authorities and industry associations, to stay current on changes and updates to industry codes and standards.
Provide training and education to internal stakeholders on codes and standards issues.
Support Audits as Codes and Standards Subject Matter Expert
Other duties may be assigned.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Apply Now

Address

Explore this location Nedre vägen 100
975 92 Luleå
Sweden Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

Join Now

Senior Engineer R&D - Codes and Standards

Overview

Success Profile

Senior Engineer R&D - Codes and Standards

Address

Share

Hear from Our Employees

Meet Reagan, Senior Research Scientist in the United States

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

Meet Amitha, Research Associate in India

Related Content

Join Our Talent Community