Description:
About the Role
We’re looking for a hands-on, experienced Process Engineer with a strong background in tooling, plastic molding, and supply chain management to join our operations team. You’ll report directly to the COO and play a critical role in managing our global manufacturing, logistics, procurement, and supplier relationships.
This role is ideal for someone who thrives in a fast-paced, high-impact environment and enjoys taking products from concept to customer with efficiency, repeatability, and regulatory compliance, especially in industries governed by ISO 13485.
Key Responsibilities
- Lead new product introductions (NPI) and support the scale-up of manufacturing processes.
- Take ownership of tooling and plastic molding , ensuring robust verification and validation of components to support repeatable production.
- Manage global supply chain operations including procurement, supplier performance, inventory, and logistics.
- Oversee validation of new equipment , including documentation in line with quality and regulatory requirements.
- Ensure compliance with ISO 13485 and support the creation of regulatory documentation as needed.
- Coordinate production, inventory control, and distribution planning.
- Manage change control processes (ECRs/ECNs), maintain technical documentation, and ensure quality compliance.
- Work closely with suppliers to reduce lead times and improve operational efficiency.
- Collaborate with Sales, Marketing, and Finance to support product launches, customer audits, and cross-functional initiatives.
- Provide regular updates on operational KPIs and project performance.
Requirements:
- Lead new product introductions (NPI) and support the scale-up of manufacturing processes.
- Take ownership of tooling and plastic molding , ensuring robust verification and validation of components to support repeatable production.
- Manage global supply chain operations including procurement, supplier performance, inventory, and logistics.
- Oversee validation of new equipment , including documentation in line with quality and regulatory requirements.
- Ensure compliance with ISO 13485 and support the creation of regulatory documentation as needed.
- Coordinate production, inventory control, and distribution planning.
- Manage change control processes (ECRs/ECNs), maintain technical documentation, and ensure quality compliance.
- Work closely with suppliers to reduce lead times and improve operational efficiency.
- Collaborate with Sales, Marketing, and Finance to support product launches, customer audits, and cross-functional initiatives.
- Provide regular updates on operational KPIs and project performance.
- A degree in Engineering, Supply Chain, Business , or a related field.
- 5+ years' experience in operations, process engineering, or supply chain management—ideally in a regulated industry .
- Proven experience in tooling, plastic moulding , and hands-on process development.
- Strong knowledge of manufacturing, logistics, and inventory systems .
- Experience with ERP systems , Excel (PivotTables), MS Project, and other planning tools.
- Strong communication, collaboration, and problem-solving skills.
- Comfortable working in a fast-paced, evolving environment .
- Willingness to travel to engage with suppliers and partners as needed.
- Familiarity with medical device regulations and documentation.
- Experience with Lean, Six Sigma, or Kaizen continuous improvement methodologies.
- Working knowledge of ISO 13485 and validation protocols in a regulated environment.
Experience:
- A degree in Engineering, Supply Chain, Business , or a related field.
- 5+ years' experience in operations, process engineering, or supply chain management—ideally in a regulated industry .
- Proven experience in tooling, plastic moulding , and hands-on process development.
- Strong knowledge of manufacturing, logistics, and inventory systems .
- Experience with ERP systems , Excel (PivotTables), MS Project, and other planning tools.
- Strong communication, collaboration, and problem-solving skills.
- Comfortable working in a fast-paced, evolving environment .
- Willingness to travel to engage with suppliers and partners as needed.
Bonus Points For
- Familiarity with medical device regulations and documentation.
- Experience with Lean, Six Sigma, or Kaizen continuous improvement methodologies.
- Working knowledge of ISO 13485 and validation protocols in a regulated environment.
30 Jul 2025;
from:
careers24.com