Sr Manufacturing Engineer

Planet Pharma; Warsaw (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma seeks an EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer to oversee and manage all EU MDR implementation activities at a designated manufacturing site. This site-based role serves as the primary liaison between the Spine EU MDR Program team and local Manufacturing, Quality, Engineering, and Operations leaders to ensure timely, compliant MDR delivery.

Responsibilities include leading site-level execution plans, coordinating cross-functional activities,

Qualifications

• Bachelor’s degree in Engineering required.
• 7 years of relevant experience, including 5+ years in project management or site leadership roles; or advanced degree with 5 years of relevant experience and 5+ years of project or site leadership experience.

Responsibilities

• Lead and manage all Spine EU MDR implementation activities within the assigned manufacturing site.
• Own site-level execution plans and schedules, ensuring alignment with the overarching Spine EU MDR implementation timeline.
• Serve as the primary point of contact between the EU MDR Program Lead and site Manufacturing leadership.
• Coordinate site execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations teams.
• Ensure site readiness and timely completion of MDR implementation deliverables, including ECO/MCO/SMECO execution, documentation updates, and system readiness.
• Track progress against milestones, identify risks or constraints, and develop mitigation plans to protect timelines.
• Escalate execution issues, capacity constraints, or dependency risks to the EU MDR Program team as needed.
• Support audits, inspections, and internal reviews by ensuring implementation activities are properly documented and traceable.
• Drive adherence to standardized MDR implementation processes while accounting for site-specific execution constraints.

Skills

Project management

Manufacturing processes

Regulatory deadlines

Education

Bachelor’s degree in Engineering

Job description

Top 3 technical skills that are required for the role:

1. project or program management experience within a manufacturing environment

2. Understanding of manufacturing processes, change control, and cross?functional coordination

3. Ability to operate effectively within fixed regulatory deadlines and constrained schedules

Education Required: Bachelor’s degree in engineering discipline required.

Years’ Experience Required:

• 7 years of relevant experience, including 5+ years in project management or site leadership roles; or
• Advanced degree with a minimum of 5 years of relevant experience and 5+ years of project or site leadership experience.

Role Summary
The EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer is responsible for overseeing and managing all EU MDR implementation activities at a designated manufacturing site. This role is site?based and accountable for driving execution of MDR deliverables in alignment with the approved implementation schedule. The individual serves as theprimary point of contact and liaisonbetween the Spine EU MDR Program team and local Manufacturing, Quality, Engineering, and Operations leaders to ensure timely, compliant implementation.

Key Responsibilities
Responsibilities may include, but are not limited to, the following:

• Lead and manage all Spine EU MDR implementation activities within the assigned manufacturing site.
• Own site?level execution plans and schedules, ensuring alignment with the overarching Spine EU MDR implementation timeline.
• Serve as the primary point of contact between the EU MDR Program Lead and site Manufacturing leadership.
• Coordinate site execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations teams.
• Ensure site readiness and timely completion of MDR implementation deliverables, including ECO/MCO/SMECO execution, documentation updates, and system readiness.
• Track progress against milestones, identify risks or constraints, and develop mitigation plans to protect committed timelines.
• Escalate execution issues, capacity constraints, or dependency risks to the EU MDR Program team as needed.
• Support audits, inspections, and internal reviews by ensuring implementation activities are properly documented and traceable.
• Drive adherence to standardized MDR implementation processes while accounting for site?specific execution constraints.
  Coordinates entry of all master data for assigned product lines
  Provides shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines. Maintains Manufacturing Process Planning documentation and ensures the accuracy of labor standards. Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.

Differentiating Factors

Autonomy

• Translates program?level EU MDR implementation strategy into executable, site?specific plans.
• Operates with significant autonomy to manage execution sequencing, resource coordination, and issue resolution at the site level.

Organizational Impact

• Directly impacts regulatory compliance, manufacturing execution, and supply continuity for Spine products.
• Decisions influence site schedules, resource utilization, and the ability to meet fixed EU MDR deadlines.
• Acts as the site owner for MDR implementation performance and readiness.

Innovation and Complexity

• Operates in a highly constrained regulatory environment with limited schedule flexibility.
• Addresses complex, interdependent execution challenges involving engineering changes, quality approvals, manufacturing readiness, and supply chain coordination.
• Adapts standardized MDR implementation approaches to local site realities without compromising compliance.

Communication and Influence

• Communicates regularly with site leadership, EU MDR Program leadership, and cross?functional stakeholders.
• Influences across functions to align priorities, resolve conflicts, and maintain execution momentum.
• Serves as the authoritative site voice for MDR implementation status, risks, and mitigation actions.

Required Knowledge and Experience

• Strong project or program management experience within a manufacturing environment.
• Experience leading site?based execution of regulated changes (regulatory, quality, engineering, or operations preferred).
• Solid understanding of manufacturing processes, change control, and cross?functional coordination.
• Ability to operate effectively within fixed regulatory deadlines and constrained schedules.
• Bachelor’s degree in Engineering discipline required.
• Minimum of 7 years of relevant experience, including 5+ years in project management or site leadership roles;or
• Advanced degree with a minimum of 5 years of relevant experience and 5+ years of project or site leadership experience.