Product Design Owner I

Baxter International Inc.•Skaneateles, NY

3d•Onsite

About The Position

This role is central to maintaining advanced connected monitoring devices that integrate real-time patient monitoring, embedded software, and hospital EMR systems, delivering seamless and secure data flow across care settings. As a PDO with software and systems expertise, you’ll bring technical insight into system architecture of hospital integration solutions utilizing your knowledge of connectivity protocols. You will be responsible for ensuring our solutions are robust, scalable, and compliant with healthcare standards. You will be responsible for the management of the design of the Baxter Front Line Care Connected Monitoring products throughout the on-market product lifecycle. The PDO is accountable for the product DHF (Design History File), DMR (Device Master Record)/Master Production and Control Record (MPCR) and Risk Management documentation, or similar product design governance documents for a particular product. As a PDO at Baxter, you will further its mission to empower clinicians and health systems with the tools to make a difference in patients and clinician’s lives. We are looking for someone who is passionate about this work, who empathizes with the functional and psychological needs of the people who experience our products firsthand.

Requirements

Bachelors Degree in Computer Science, Mechanical, Electrical, Biomedical Engineering or other relevant subject areas with 5+ years of proven experience.
5+ years in product design, systems and risk engineering within the medical device industry.
Proven track record in software-enabled product development, especially involving connectivity (Bluetooth, Wi-Fi).
Proven application of knowledge in Hardware, Software, and System engineering.
Have the knowledge of the regulatory environment for design, development and manufacturing.
Knowledge of manufacturing practices and improvements (yield improvements, etc.) sufficient to be able to assess changes, incremental risks.
Actively facilitates and negotiates to drive the closure on product/program-related decisions/issues.
Ability to work collaboratively as part of a global multi-functional team.

Nice To Haves

Familiarity with IEC, ISO, FDA and other regulatory standards and GMP/QSR environment preferred.

Responsibilities

Has authority and accountability to maintain and/or update the product design.
As key team member of the Connected Monitoring Core Team, responsible for providing technical assessment inputs & associated risks in enabling the Business Priority decision for the product and/or design change along with commercial and program inputs.
Ensures compliance, quality, and continuity of products in the market.
Ensures consideration of input from external/internal stakeholders (Market, Customer, Regulatory/Compliance, Quality, Service, Manufacturing etc.), drive conflicts to resolution, drive team to agree to a unified decision and drives consideration of these inputs into implementable design solutions.
Works on the technical challenges and risk scenarios and prepares, leads & executes mitigations to ensure optimal results in conjunction with the Sustaining Engineering organization.
Ensures Design Reviews and technical reviews are conducted as required by the quality system.
Approves, controls, and owns Design History File (DHF) elements (may or may not be authoring), Product and Process Changes, including managing the Risk Management Assessment in conjunction with the Product Risk Management Owner.
Responsible to drive continuous adherence to FDA, ISO, and IEC design control procedures, regulations and standards ensuring the product compliance and regulatory changes/new geographic expansion needs.
Utilizes current product knowledge to facilitate change control when required for product support post-market such as SNCR, SCAR, complaint investigation) or updates to the DHF and technical documentation.
Approves the impact assessment of the change and necessary actions.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits