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Lead Mechanical Process Engineer

2 months ago

Mississauga, Ontario, Canada Boston Scientific Full time

Location: Canada

Core Values: Diversity - Innovation - Compassion - Global Collaboration - Competitive Spirit - High Performance

At Boston Scientific, we empower you to unlock your potential by collaborating with a diverse and high-achieving workforce, addressing significant challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we support your professional growth and aspirations.

Position Overview

Are you enthusiastic about mechanical engineering and process enhancement? We are seeking a Senior Process Engineer to become an integral part of our innovative Process Development Team, playing a pivotal role in the evolution of medical device production. Collaborating with a skilled team of engineers and process experts, you will engage with both local and international teams to develop groundbreaking, state-of-the-art technologies.

Key Responsibilities:

  • Lead the exploration, design, and assessment of mechanical materials, components, assemblies, and processes that propel our technology forward.
  • Conduct comprehensive feasibility analyses to validate the functionality and capability of new designs and processes, ensuring adherence to the highest standards.
  • Utilize your technical knowledge to innovate, design, and develop new processes, tools, and automation that enhance manufacturing efficiency.
  • Oversee vendor activities, ensuring seamless integration and support for development initiatives.
  • Employ your expertise in machine design principles and CAD modeling (such as SolidWorks) to produce and communicate intricate technical drawings and presentations.
  • Design and implement structured experimental plans that facilitate data-driven decisions, leading to improvements in products and processes.
  • Collaborate closely with subject matter experts (SMEs) and R&D teams to develop product concepts, influence design specifications, and provide valuable Design for Manufacturability (DFM) insights.
  • Develop and manage critical processes for complex devices in a pilot environment, ensuring robust and capable operations.
  • Address complex technical challenges in a hands-on manner, contributing to a dynamic and innovative work atmosphere.
  • Provide structured leadership and problem-solving to drive product and process innovation, guiding the team through strategic development cycles.
  • Contribute ideas or generate Intellectual Property submissions that safeguard and enhance our technological advancements.
  • Evaluate process capabilities, prioritize improvement opportunities, and implement innovative solutions for platform and derivative projects.
  • Execute functional deliverables associated with Product Development Process (PDP)/Technology Development Process (TDP), Project Management, and Quality Systems, ensuring successful project outcomes.
  • Organize and conduct all aspects of technical reviews, providing clear communication and updates to stakeholders.
  • Excel in situations with a high level of ambiguity, working independently to address non-routine challenges and deliver results.
  • Guide and mentor technicians and entry-level engineers, fostering a collaborative and innovative team environment.
  • Develop, write, and review process validation strategies and related deliverables, such as experiment technical reports, GR&R, TMV, IQ, FMEA's, etc., to meet quality system requirements.
  • Adhere to all requirements of the Quality Management System, demonstrate company values, and comply with Health & Safety policies.
  • Occasional travel may be required, up to 15%.

Required Qualifications:

  • Degree in Engineering or a related field.
  • 5+ years of relevant professional experience.
  • Proficiency in CAD software and simulation tools.
  • Strong understanding of manufacturing processes, materials, and techniques.
  • Proven ability to develop processes, fixtures, and equipment from concept to production.
  • Strong mechanical aptitude with experience in fixture and equipment design or troubleshooting.
  • Excellent organizational, communication, and collaboration skills.

Preferred Qualifications:

  • Bachelor's degree in Mechanical, Electrical, or Mechatronics Engineering.
  • Extensive experience in the medical device industry or other regulated sectors.
  • Expertise in process development, focusing on equipment validation, process characterization, and overall validation processes.
  • Hands-on experience with plastics, metals, and various joining methods, demonstrating a broad range of material expertise.
  • Highly desirable experience in medical device manufacturing, particularly with sheaths, catheters, dilators, and similar products.
  • Certified SolidWorks Professional (CSWP) with demonstrated proficiency.
  • Strong analytical skills in assessing business needs, identifying effective solutions, and implementing them efficiently.
  • Expert in automating systems, integrating equipment, and developing vision systems, with strong knowledge of advanced automation technologies.
  • Experience selecting and sizing electro-mechanical components (servo motors, sensors, pneumatics, heaters) and motion control.

Requisition ID: 587025

As a leader in medical science for over 40 years, we are dedicated to addressing the most pressing challenges – united by a profound commitment to human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that enhance patient outcomes, create value for our customers, and support our employees and the communities we serve.

At Boston Scientific, we believe that fostering a diverse and inclusive workplace drives innovation and is crucial in our mission to advance science for life and improve patient health. We advocate for inclusion, equality, and opportunity for all. By embracing the richness of our diverse backgrounds and perspectives, we create a more rewarding environment for our employees and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a workplace free from prohibited substances. We are committed to complying with all applicable state and federal laws and healthcare credentialing requirements.