Principal Engineer, OpEx

Baxter•Skaneateles Falls, NY

About The Position

The Principal Engineer, Operational Excellence (OpEx) leads continuous improvement initiatives across the organization to enhance operational efficiency, product quality, and overall performance. The role applies Lean Manufacturing, Six Sigma, and other best practices in a mechanical and electrical manufacturing environment, supporting organizational goals and the Lean Daily Management System. The position manages OpEx projects from inception through completion, analyzes operational data and performance metrics, and reports project outcomes to senior management and stakeholders. It also trains and mentors employees, leads workshops and Kaizen events, and works with engineering, quality assurance, production, regulatory affairs, and other groups to integrate improvements into daily operations. The Principal Engineer helps ensure continuous improvement activities meet relevant regulatory standards and quality management systems, including FDA and ISO 13485 requirements. The role also keeps current with manufacturing and continuous improvement trends and technologies, identifies innovative solutions, and performs other duties assigned by management. Employees are expected to follow environmental, health, safety, quality, regulatory, legal, and ethical requirements, report hazards and incidents, and contribute to preventing harm.

Requirements

Bachelor’s degree in engineering, industrial engineering, or manufacturing.
At least 7 years of experience in continuous improvement, process engineering, or operations management, preferably in the medical device or healthcare industry.
Strong expertise in Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
Excellent analytical and problem-solving skills, with a data-driven approach to decision-making.
Strong project management skills and the ability to lead cross-functional teams and manage multiple projects simultaneously.
Excellent verbal and written communication skills, with the ability to influence and engage stakeholders at all levels.
Authorization to work for any employer in the United States; visa sponsorship or takeover of sponsorship is not available.

Nice To Haves

Master’s degree.
Lean Six Sigma certification (Black Belt or Master Black Belt) or equivalent.
Experience with quality management systems and regulatory requirements in the medical device industry.
Familiarity with statistical analysis software and tools such as Minitab or JMP.

Responsibilities

Lead continuous improvement initiatives across manufacturing and operational processes to improve efficiency, reduce waste, and enhance product quality.
Develop and implement continuous improvement strategies and methodologies, including Lean and Six Sigma.
Implement and support Lean Daily Management System processes throughout the organization.
Manage OpEx projects from inception to completion, ensuring alignment with business objectives and timelines.
Collaborate with cross-functional teams to identify improvement opportunities, define project scope, and establish measurable goals.
Analyze operational data and performance metrics to identify trends, root causes, and areas for improvement.
Prepare and present reports on OpEx initiatives, project outcomes, and performance improvements to senior management and stakeholders.
Train and mentor employees in Lean and OpEx methodologies, tools, and techniques.
Lead workshops and Kaizen events to engage teams in problem-solving and process improvement.
Collaborate with engineering, quality assurance, production, and other departments to integrate OpEx initiatives into daily operations.
Communicate project updates, challenges, and successes to stakeholders at all levels.
Ensure continuous improvement activities comply with applicable regulatory standards and quality management systems, including FDA and ISO 13485 requirements.
Work with regulatory affairs teams to support compliance efforts related to continuous improvement initiatives.
Stay current with industry trends, emerging technologies, and best practices in continuous improvement and manufacturing.
Identify and implement innovative solutions to improve operational performance and competitive advantage.
Perform other duties assigned by management to support the continuous improvement team.
Follow legal and corporate EHS requirements, safe work practices, and EHS policies and procedures; report hazards, near misses, and incidents and participate in actions to prevent harm.
Support departmental quality and regulatory performance, including compliance with GMP, FDA, ISO, other government regulations, legal documents, safety and ethical standards, and required compliance training.

Benefits

Medical and dental coverage beginning on day one.
Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with 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.
Childcare benefits.
Position may be eligible for discretionary bonuses.