Principal Eng, Risk

Vantive; Hinoba-an; On-site; PHP 900,000 - 1,500,000; Full time

Job summary

Vantive is advancing vital organ therapies by delivering digital solutions and services to care teams and patients worldwide. This role provides technical leadership in Risk Management for Device Engineering, guiding RM activities from development through post-market stages and collaborating with cross-functional teams to ensure product safety and effectiveness.

You will drive risk analysis, define verification and validation needs, and align with IEC/ISO standards while advocating for

Qualifications

• Bachelor or Master in Engineering with 7–10 years in electromechanical medical device design.
• Experience leading Risk Management for medical devices and design controls.
• Knowledge of ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633.
• Six Sigma Green/Black Belt or LEAN certification preferred.

Responsibilities

• Lead Risk Management activities for products across the lifecycle from development to post-market surveillance.
• Provide ongoing risk analysis and identify required risk mitigations to ensure safe, effective products.
• Define requirements and verification/validation testing to mitigate risk.
• Drive completion of Risk Management activities towards design transfer and commercialization.
• Provide leadership and SME guidance to ensure RM principles are applied throughout development.
• Create and approve Design History File deliverables related to Risk Management.
• Assess and improve RM processes and interrelationships with Reliability.

Skills

English fluency

Verbal and written communication

Analytical thinking

Documentation standards

Project collaboration

Budget and timeline management

FMEA knowledge

Education

BS/MS in Engineering

Tools

WebEx

Teams

Microsoft Office

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Provide technical leadership in Risk Management activities for Device Engineering. Drive standardized execution of Risk Management process that is effective, efficient, and compliant with Baxter processes and Regulatory Standards.

Job Responsibilities:

• Responsible for leading the activities associated with the Risk Management of products in various stages of the product lifecycle from new product development to post-market surveillance.
• Provides ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product.
• Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk
• Drive completion of Risk Management activities towards design transfer and successful commercialization of new products.
• Provides leadership and subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
• Creates and approves Design History File deliverables associated with Risk Management.
• Assesses and improves the Risk Management process.
• Facilitate an improved understanding of the interrelationship between Risk and Reliability.
• Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.
• Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
• Collaborates with Engineering, Manufacturing, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files. Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812).
• Recognizes strategy, evaluates risks, recommends actions, and develops contingencies to address various scenarios. Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward.
• Motivates and successfully influences stakeholders and cross-functional team members within the project.

Qualifications

• BS/MS degree in Engineering, with approximately 7-10 years (5-7 years w/ MS) of practical Electromechanical Medical Device Design experience.
• Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project.
• Six Sigma Green belt or Black Belt (DFSS) certification preferred; LEAN certification preferred
• Must have a good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
• Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
• Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.).
• Membership and/or certification in a professional organization a plus (e.g. INCOSE).

Skills

• Excellent English verbal and written communication skills. Clear and effective communication (written and oral) and presentation skills.
• Computer skills: email, documentation, and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, etc.
• Self-directed, resourceful, and able to work on multiple projects and priorities. A strong collaborator able to work independently and in a team
• Analytical, detail-oriented, thorough, and accurate. Open to accepting critiques and striving for continuous improvement in every task
• Focused on consistency, using style guides, branding guidelines, and company procedures to produce documentation
• A proven track record of effectiveness in a fast-paced environment.
• Proven ability to create results within budget, timeline, and product/project deliverables.

Reasonable Accommodation

Vantive 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. Form Link