Principal Process & Equipment Engineer

 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity, and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview. 

About the Role:

Responsible for providing engineering support and expertise, specific to equipment controls, software and automation in the definition, design and test of products through engineering solutions that meet regulatory requirements.

Your Responsibilities Include:

• Develop comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
• Provide project estimates independently and review quotes of Engineer I’s, II's and Senior Engineers (as needed).
• Submit specification, protocol and report for approvals and documentation control via a Change Request.
• Develop comprehensive software validations and equipment installation qualification protocols per the specification.
• Execute software validation and/or qualification protocols & record results.
• Document, communicate and follow-up on software/equipment issues.
• Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.
• Create documents, links and Change Requests utilizing a Product Data Management system.
• Provide expert information on FDA/QSR regulations and corporate and internal process validation policies pertaining to software validations, electronic records & signatures, equipment qualifications to project team.
• Perform project lead activities on small to large-scale validation/qualification projects.  Participate in vendor evaluations.
• Provide guidance, mentoring and training to Engineer I's & II's and Senior Engineers.  Ensure consistency of work among Engineer I's & II's.  Provide peer reviews on specifications, protocols and reports.
• Drive the standards for validating and qualifying new technologies and/or software systems cross-functionally.
• Influences and defines functional, departmental, divisional and corporate policies and procedures through involvement with cross-functional engineering initiatives.
• Provide leadership role on championing functional best practices.
• Develop and review comprehensive validation procedures in compliance with FDA.

What We’re Looking For:

• Licentiate degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related.
• English Level: C1: 90-94%.
• Desired knowledge: Automation Technologies (Robotics, PLC, Vision, Motion, Sensing, etc.); Equipment Design, Building & Machining; Equipment Maintenance; Tools (2D & 3D CAD, Statistics, Technical Manuals); Problem Solving Methodologies.
• At least 7 years of experience in similar position.

Requisition ID: 594264

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.