Baxter - Made in Italy · 4 hours ago
Senior Engineer Manufacturing
Baxter is a company dedicated to redefining healthcare delivery and ensuring every individual has a chance to live a healthy life. The Senior Engineer Manufacturing will optimize manufacturing processes and ensure the efficient production of high-quality medical devices, collaborating with cross-functional teams to drive continuous improvement initiatives and enhance operational efficiency.
Consumer GoodsFurnitureManufacturingRetail
Responsibilities
Provide technical expertise and support to manufacturing teams for 10-12 medical device manufacturing assembly lines (e.g. Electronics, Machining, Plating, Manual Assembly), troubleshooting and resolving production issues
Develop and maintain manufacturing process documentation such as Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventative Maintenance, and Calibration procedures through the Engineering Change Management (ECM) process
Conduct root cause analysis and implement corrective actions to address process deviations and equipment failures
Develop and execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements
Develop and execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements
Perform and document Impact Assessments and Corrective Actions for Equipment Remediation’s associated with out of tolerance calibration results
Analyze and improve manufacturing processes to enhance efficiency, reduce waste, and increase productivity
Develop and implement process control strategies to ensure consistent product quality and compliance with regulatory standards
Lead and manage engineering projects from conception through implementation, ensuring they are completed on time and within budget
Collaborate with cross-functional teams, including production, quality assurance, and supply chain, to align project goals with business objectives
Prepare and maintain accurate documentation related to manufacturing processes, including work instructions, process flows, and validation protocols
Guarantee alignment with all relevant safety regulations, industry standards, and company policies
Identify and implement continuous improvement initiatives using Lean, Six Sigma, and other methodologies to enhance manufacturing performance
Monitor key performance indicators (KPIs) and develop action plans to achieve operational goals
Mentor and train junior engineers and manufacturing staff on best practices, process improvements, and new technologies
Foster a culture of learning and development within the engineering team
Perform other duties as assigned by management to support the overall goals of the quality team
Proactively contributes to zero harm in the workplace by always following legal and corporate Environmental Health & Safety requirements. This includes safe work practices and EHS policies and procedures that protect every employee
Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment
Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met
Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training
Ensure that all testing activities comply with relevant regulatory standards and quality management systems (e.g., ISO 13485, FDA regulations)
Report any safety concerns or incidents to management in a timely and accurate manner
Qualification
Required
Bachelor's degree in mechanical engineering, Industrial Engineering, Manufacturing Engineering, or a related field; a master's degree is preferred
Minimum of 3-7 years of experience in manufacturing engineering or a related field, preferably in a regulated industry such as medical devices or pharmaceuticals
Proven experience in project management and process improvement initiatives
Strong knowledge of manufacturing processes, equipment, and technologies
Proficient in CAD software and manufacturing simulation tools
Excellent analytical and problem-solving skills, with the ability to work under pressure
Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
OSHA certification (e.g., 30-hour or 40-hour)
Employees at every level are responsible for quality (GMP) Good Manufacturing Processes and regulatory performance in the department to ensure quality program is met
Ensure compliance with FDA, ISO and other government regulations, legal documents and safety and ethical standards, obtaining legal compliance training
Ensure that all testing activities comply with relevant regulatory standards and quality management systems (e.g., ISO 13485, FDA regulations)
Proactively contributes to zero harm in the workplace by always following legal and corporate Environmental Health & Safety requirements
Report all hazards, near misses and incidents as soon as practicable and participate in identifying actions to prevent harm from occurring to our people and/or our environment
Preferred
Experience in the Medical Device or a similar regulated industry is preferred
SAP, CAD modeling, Schematic drafting, PLC & CNC programming experience is a plus
Other certifications (e.g., biomedical engineering, electrical engineering) and Lean Six Sigma certification or equivalent
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
Company
Baxter - Made in Italy
Baxter is an Italian company founded in 1990 in that cultural and territorial melting pot where the high-end furniture production experience of Brianza meets the knowledge of design capital Milan, hub of Italian creativity.
Funding
Current Stage
Growth StageRecent News
EIN Presswire
2026-01-22
Medical Device Network
2026-01-19
MedCity News
2026-01-17
Company data provided by crunchbase