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A Day in the Life

Principal Manufacturing Engineer- Global Contract Manufacturing

A Day In The Life
Provide manufacturing engineering support to enable the successful management and optimization of manufacturing lines within the Global Contract Manufacturing Platform. Work collaboratively with our internal businesses, global Cross functions and contract manufacturing partners to identify and mitigate risks, drive continuous improvement and maintain consistent service performance from active production lines.

Responsibilities may include the following and other duties may be assigned.

·        Develop, validate, and maintain production fixtures for medical devices and subassemblies.

·        Support day‑to‑day manufacturing operations by troubleshooting test failures, equipment issues, and process deviations.

·        Create and execute validation protocols (IQ/OQ/PQ) for equipment and manufacturing processes.

·        Ensure all production systems remain compliant, calibrated, and audit‑ready.

·        Collaborate with Quality and Regulatory teams to maintain documentation aligned with ISO 13485 and FDA 21 CFR Part 820 requirements.

·        Drive improvements in throughput, and reliability through automation, fixture upgrades, and process optimization.

·        Analyze test data to identify trends, recurring issues, and opportunities for improvement.

·        Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

·        Implement root‑cause analysis and corrective/preventive actions (CAPA) for test‑related issues.

·        Develop and implement manufacturing processes that are applicable to statistical process control and may develop those techniques.

·        Contribute to lean manufacturing initiatives and efficiency projects.

·        Designs arrangement of machines within manufacturing facilities to ensure most efficient and productive layout.

·        Designs sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.

·        Adapts machine or equipment design to factory and production conditions.

·        May incorporate inspection and test requirements into the production plan.

·        Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

·        Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

·        Ensuring processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. Partner with Manufacturing Engineering to ensure seamless integration of test processes into production lines.

DIFFERENTIATING FACTORS

Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower-level specialists.

Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develop solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.

Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience: 

• Bachelor’s degree required

• Minimum of 7 years of relevant medical device manufacturing engineering experience or related field, or advanced degree with 5 years of relevant medical device manufacturing engineering experience or related field.

• Must have project planning skills to prioritize tasks and establish framework and systems for managing areas of responsibility.

• Experience working in an FDA regulated industry, familiarity with requirements management and IQ, OQ, PQ

• Strong technical engineering background, able to understand engineering drawings, specs and true design intent.

• Strong understanding of measurement systems, instrumentation, and data acquisition.

• Must have good written and oral communication skills (English)

• Strong manufacturing and/or regulatory environment experience in Active Medical device or equipment company.

• Demonstrate success leading teams/and/or matrix organizations

• Excellent presentation and communication skills

• Strong business acumen and understanding of operations costing (LBM, OPC, inventory deferrals, etc.)

• Excellent problem‑solving skills and comfort working on a fast‑paced production floor.

• Experience with statistical analysis tools (e.g., Minitab, JMP) and process capability metrics.

• Knowledge of risk management, FMEA, and root‑cause analysis methodologies. 

Preferred Experience: Experience working on a range of scales and complexity of product from large capital equipment to small, less complex consumables. Experience working with contract manufacturing finished goods suppliers.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.