Process Engineering Manager THVs

Corcym; Burnaby; On-site; CAD 90,000 - 120,000; Full time

Job summary

A global medical device company seeks a Process Engineering Manager to lead a team, improve manufacturing processes, and ensure compliance with quality standards. The role requires strong technical knowledge, team management skills, and experience in process development. Join a dedicated team focused on innovative surgical solutions for heart disease.

Qualifications

• At least 5 years of experience in Manufacturing technologies and Process Development.
• At least 5 years of experience managing people or large teams.

Responsibilities

• Coordinate and supervise Process Engineers.
• Drive projects within Process Engineering scope.
• Support resolution of non-conformities and CAPAs.

Skills

Problem Solving

Team Management

Lean Manufacturing

Quality Control

Risk Analysis

Education

Master's degree in Science or Engineering

Tools

Microsoft Office

Minitab

Job description

Joinus today and take life to heart!

CORCYM is a global, independent, medical device company entirely focused on state-of-the-art surgical solutions to fight structural heart disease. CORCYM has a presence in more than 100 countries with approximately 850 employees and ensures strong continuous support to patients, healthcare professionals and healthcare systems worldwide.

Who We Are:
Corcym offers a complete portfolio of surgical solutions with a heritage spanning more than 50 years, leveraging on a complete and distinctive set of technologies, capabilities and infrastructure.

Our Vision:
is to become the leading company dedicated to Heart Surgeons and their Patients by providing the best solutions to fight structural heart disease.

Our Mission:
is to help Heart Surgeons treat Patients better today and in the future.

Process Engineering Manager:

The Process Engineering Manager coordinates and supervises the activities of a team formed by Process Engineers. He/she is responsible for the improvement, qualification and monitoring of manufacturing processes and products. He/she drives projects within Process Engineering scope, supports manufacturing and product development, continuous improvement strategy and Operational Excellence projects
and manages relation with other functions, aimed to maintain and improve industrial performance.

Key Responsibilities:

· Team management, establishing objectives, evaluating performances, and supporting people development.

· Responsible for the technical management of specific areas/product lines: Tissue Heart Valves, Lean Manufacturing

· Collaborate to share the knowledge of quality controls and manufacturing processes.

· Responsible to support other departments and Production Managers to define and implement improvement projects, new process/product development, and business continuity projects.

· Responsible to support the resolution of non-conformities and CAPAs.

· Collaborate with Production Managers, Finance and Purchasing to achieve strategic KPIs of the plant.

· Responsible to support transfer and qualification/validation of new manufacturing processes, products and new technologies/automation (including IQ, OQ, PQ, FMEA, Risk Analysis).

· Execute and Report on status of Lean manufacturing / Continuous Improvement projects

· Responsible to support the preventive maintenance design

· Responsible for the technical documentation preparation and review.

· Collaborate in the evaluation of external suppliers or new products/materials qualification.

· Ensure the support in cross functional project teams to guide or support the implementation of the strategic projects of the HV Industrial Area.

· Responsible to operate in conformity to QMS procedures and answer to the auditor for the area of his/her experience

· Safety & Integrity: ensures all employees in the function understand Group safety and integrity standards and act accordingly. Acts as a personal role model for the organization in this regard. Contributes to effective risk management by providing advice on key Group policy decisions.

Knowledge, Skills and Abilities:

· Strong technical knowledge of manufacturing processes in relation to manufacturing and quality aspects: deep knowledge of THVs processes, dimensional and visual inspection

· Expert in SPC, root causes analysis and problem solving techniques

· Expert of validation and verification techniques (Test Plan, Test Report, FMEA, risk analysis)

· Good knowledge of Six Sigma principles (green belt certification or black belt is a plus)

· Good knowledge of Medical Device manufacturing regulations

· Good knowledge of common software (Microsoft Office), knowledge of Minitab

· Good management of financial data and manufacturing KPI's

· Basic knowledge of Electronic and Software technologies

· Basic chemical process knowledge

· Possesses in depth knowledge of pertinent regulations (e.g., MDD, ISO 13485 and 21 CRF Part 820) to ensure the documentation of all company-wide functions meet these requirements and, when necessary

· Proficient written and spoken English

· Excellent people management skills

· Ability to relate to other middle managers inside organization

· Provenability to motivate and drive the team

· Focused to results achievement

· Experienced in fostering teamwork and collaboration inside and outside the team

· Skilled at developing and engaging collaborators

Experience:

· At least 5 years of experience resolving problems related to Manufacturing technologies and Process Development

· At least 5 years of experience managing people or large teams

Education:

· Master's degree in Science or Engineering