Software Eng - P4

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 120,000 - 210,000; Full time

Job summary

Boston Scientific Malaysia is seeking an experienced software engineer to lead the development of control systems and automation solutions for medical device production. You will design PC/PLC-based controls, implement device-to-device and device-to-cloud communications, and guide cross-functional teams through validation and deployment.

You will collaborate with Equipment Design, Maintenance, and Manufacturing, ensure software quality and regulatory compliance (21 CFR Part 11 in spirit), and

Qualifications

• Bachelor’s degree in engineering with focus on software/automation.
• 9+ years in industrial software development, control systems, and manufacturing automation.
• Experience with PLC/PC-based solutions and equipment integration.
• Experience leading technical projects and supporting manufacturing equipment systems.
• Knowledge of software validation requirements in regulated manufacturing environments.

Responsibilities

• Participates on project teams to develop clear specifications and provide estimates for control systems and equipment integration designs.
• Develop applications on-premises/cloud (device-to-device or device-to-cloud communications) to support production and machine integration.
• Designs control systems (PC and PLC based) and solutions.
• Coordinate, monitor, and document project designs, estimates, costs, schedules, and scope changes.
• Prepare reports to communicate status and results; deliver data-driven insights through dashboards and visualizations.
• Lead project teams including Designers, Engineers and Technicians; champion best practices.
• Collaborate with stakeholders to elicit requirements and translate into technology solutions.
• Manage incident response for equipment failures with recovery plans and resources.
• Ensure best software practices maximize equipment effectiveness; provide software development leadership.
• Determine contract staff levels and skills to meet development needs; ensure compliance with software validation policies.
• Provide software support to Equipment Design, Maintenance and Manufacturing groups.
• Review software design specifications and documentation for equipment and systems (and 21 CFR Part 11 compliance).

Skills

Software development

PLC/PC-based control

Industrial controls

Equipment integration

Device-to-device/Device-to-cloud

Project management

Data visualization

Software validation

Troubleshooting

Communication

Analytical thinking

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s Degree in Software/Computer/Electrical/Electronic/Automation Engineering

Job description

• Participates on project teams to develop clear specifications, evaluates feasibility of concepts, and provides formal estimates for control systems and equipment integration system designs.
• Develop applications on-prem/cloud (device-to-device communications or device-to-cloud communications) and selection of specifies control components that support production and machine integration.
• Designs control systems and (PC and PLC based) solutions.
• Coordinates, monitors and documents project designs, estimates, and costs. Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements.
• Prepares standard reports/documentation to communicate status and results. Deliver data-driven insights, produce timely and actionable information to help drive business results through effective dashboards and visualizations.
• Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of issue. Provide leadership role on championing functional best practices.
• Opportunity to learn or implement industrial controls software.
• Influences and defines functional, departmental/divisional procedures through involvement with cross-functional engineering initiatives.
• Provides training as required to ensure that the solutions can be operated effectively.
• Collaborate with internal stakeholders to elicit requirements and transform them into technology solutions.
• Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.
• Ensure best software practices are employed by the group so as to maximize equipment effectiveness.
• Provide software development leadership and be the final arbitrator on choices/conflicts.
• Determines appropriate contract staff levels and skills in order to meet the plant software development requirements.
• Directs the development of and ensures compliance with Software Validation/Control policies, and procedures.
• Ensure compliance with Equipment Engineering procedures.
• Provides software support to the Equipment Design, Maintenance, and Manufacturing groups.
• Reviews software design specifications and associated documentation for equipment and systems.
• Familiar with all aspects of software validations and 21 CFR Part 11 Issues for electronic records and signatures.

Key Responsibilities

• Participates on project teams to develop clear specifications, evaluates feasibility of concepts, and provides formal estimates for control systems and equipment integration system designs.
• Develop applications on-prem/cloud (device-to-device communications or device-to-cloud communications) and selection of specifies control components that support production and machine integration.
• Designs control systems and (PC and PLC based) solutions.
• Coordinates, monitors and documents project designs, estimates, and costs. Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements.
• Prepares standard reports/documentation to communicate status and results. Deliver data-driven insights, produce timely and actionable information to help drive business results through effective dashboards and visualizations.
• Leads project teams that include Designers, Engineers and Technicians in the design, assembly, and debug of issue. Provide leadership role on championing functional best practices.
• Opportunity to learn or implement industrial controls software.
• Influences and defines functional, departmental/divisional procedures through involvement with cross-functional engineering initiatives.
• Provides training as required to ensure that the solutions can be operated effectively.
• Collaborate with internal stakeholders to elicit requirements and transform them into technology solutions.
• Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.
• Ensure best software practices are employed by the group so as to maximize equipment effectiveness.
• Provide software development leadership and be the final arbitrator on choices/conflicts.
• Determines appropriate contract staff levels and skills in order to meet the plant software development requirements.
• Directs the development of and ensures compliance with Software Validation/Control policies, and procedures.
• Ensure compliance with Equipment Engineering procedures.
• Provides software support to the Equipment Design, Maintenance, and Manufacturing groups.
• Reviews software design specifications and associated documentation for equipment and systems.
• Familiar with all aspects of software validations and 21 CFR Part 11 Issues for electronic records and signatures.

Requirements

• Bachelor’s Degree in Software Engineering, Computer Engineering, Electrical/Electronic Engineering, Automation, or related engineering discipline.
• Minimum 9 years of experience inindustrial software development, control systems, and manufacturing automation environments.
• Experience with PLC/PC-based solutions, equipment integration, and software validation activities.
• Experience leading technical projects and supporting manufacturing equipment systems.
• Knowledge of software validation requirements within a regulated manufacturing environment.
• Experience in equipment troubleshooting, automation, and system integration projects.

Required Skills

• Software development.
• PLC/PC-based control systems.
• Industrial controls and automation.
• Equipment integration.
• Device-to-device and device-to-cloud communication.
• Troubleshooting and root cause analysis.
• Project management.
• Data visualization and dashboard development.
• Software validation.
• Problem solving and analytical thinking.
• Strong communication and stakeholder management skills.
• Cross-functional collaboration and leadership.
• Knowledge of Quality System requirements.
• Knowledge of 21 CFR Part 11 requirements.
• Technical coaching and mentoring capabilities.

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding our footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.