Senior Engineer R&D - Codes and Standards

Presentation:

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)