Senior Manufacturing Engineering Manager

701 – Manufacturing       ·          Macquarie Park, New South Wales        ·       Full time

About Saluda Medical

Saluda Medical is the pioneer in closed-loop Spinal Cord Stimulation (SCS), a ground-breaking SCS therapy that can measure the spinal cord’s response to stimulation and make real-time adjustments to therapy. We are a cutting edge, progressive Australian based Medical Device company with offices and employees based in Europe, Australia, and the U.S We are at the forefront of spinal cord stimulation technologies for the management of chronic pain. 

What We’re Looking For…

You are a seasoned manager, understanding how to lead a skilled team in a manufacturing context. You are just as comfortable gowning up in a Cleanroom environment to see firsthand the issues on the production line as you are in a leadership meeting resolving issues and discussing strategy.

This role will suit someone with a background in Engineering, who has lead teams of engineers before. We are a small manufacturing site and your role is to maintain efficient and productive support to all production areas. This is done through implementation of day-to-day production and process improvements, as well as supporting production operations with all engineering and technical services, to ensure manufacturing KPIs are met on time, within budget and in a safe, quality-controlled environment.

Your role will include:

• Ensure successful establishment and of production lines, including appropriate equipment selection, testing, installation, validation and operator training.
• Sustain all production lines and processes in a qualified state, including appropriate equipment selection, installation, maintenance & calibration, validation, documentation and training.
• Ensure the timely and successful transfer and ramp up of products from product development into full production through establishing efficient, stable and repeatable manufacturing processes in collaboration with the product development teams and suppliers.
• Development and implementation of manufacturing and production engineering practices as well as plan, organise, implement, and review engineering structure and activities.
• Manage and review changes in BOMs, system build standards, and ensure correct part numbering and structure accuracy.
• Assist in the analysis and documentation of production requirements for Saluda Medical products.
• Implement and support QA functions (quality records, product inspections, etc.) related to materials, supplies, and products throughout company.
• Ensure process validation and implementation of changes are performed in line with Saluda’s Quality Management System and regulatory requirements. 
• Ensure high levels of documentation standards are maintained for all documents prepared by Manufacturing Engineering team. 
• Build, manage and develop a high performing Manufacturing Engineering team who are committed to product quality and improving efficiencies (yields).
• Assist with the assessment and selection of suitable design and manufacturing approaches.
• Assist in the management of time and cost aspects of development projects.
• Look for process improvement opportunities.
• Lead the weekly spot checks of all production lines, facilities and utilities, ensure findings are promptly tracked, resolved, reported and shared with stakeholders. 
• Support manufacturing and supply chain operations, to ensure continuous and uninterrupted flow of quality and compliant product, as per the agreed production demand plan. 
• Establish and improve standard operating procedures (SOP’s) and DMRs, such as work instructions, inspection criteria and tool manuals (WI’s).  
• Contribute to process improvement activities, including documentation changes, implementation plans, training that support the production areas and DHR templates.
• Manage and review changes in DMRs (incl. product BOMs, system build standards, MQP, PPP, MVP) and ensure correct part naming, numbering and structure accuracy.
• Demonstrate WH&S leadership and due diligence through active promotion of workplace health and safety standards and procedures and ensure that people are suitably trained to perform roles effectively and safely. Maintain a tidy and safe workplace and storage areas.
• Lead the maintenance and calibration of all production equipment, as well as supporting the sustaining of all manufacturing facilities & utilities.
• Lead the development, implementation and sustaining of a total asset management (TAM) program, covering existing processes and processes under development.
• Ensure timely review and control of tool manuals. Manage documentation updates to ensure all maintenance & calibrations tasks are clearly identified, performed and documented in a compliant
• Encourage teamwork and lead by example.
• Develop an appropriate and flexible organisational structure, to ensure that the team provides the required service levels.
• Lead in the practice of established process to promote communication, respect, teamwork, performance and professionalism.
• Perform annual and interim performance reviews, but also provide real-time performance and development feedback to engineering team members. 
• Recommend people for recruitment, promotion, development through secondment, and address performance issues expediently.
• Identify and recommend technical training requirements for the team.
• Build capability of the team to attract, develop and retain the best team members and top talent, to deliver Saluda’s current and future business objectives by ensuring people understand and are held accountable for the Saluda’s leadership standards.

About you:

• A Bachelor’s degree or higher in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering or related discipline.
• Formal training in systems, process, or manufacturing engineering.
• At least 8 years of experience in a manufacturing engineering environment.
• At least 3 years of experience in regulated (FDA, TGA, TUV) environment. 
• Proven ability to coach, develop, engage and effectively manage the performance of engineering teams.
• Working knowledge of regulatory requirements and experience with working in a quality-controlled environment.
• Experience in working within Production Management system (e.g. Lean, Six Sigma).
• Ability to produce reports & presentations to a professional standard.
• Experienced word processing and spread sheets.
• Excellent written and verbal communication skills.
• Proven competencies in problem solving, decision making, design transfer, manufacturing / business process development and personal influence.

It’s not essential, but nice if you have:

• Experience with active implantable devices or the Neuromodulation industry.
• Have worked in a formal quality assured environment such as ISO 9001 or ISO 13485.
• Experience in medical device design and development.
• Working knowledge of human resource management principles and practices

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt.

Are you Ready to Join? If you would like to be part of our team developing the world’s next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you! Please APPLY NOW!

Applications will only be considered from candidates with the appropriate approval to work in Australia, no visa or sponsorship is available for this role.

Saluda Medical is a class 3 medical device company; we support the health of our patients, our vendors, and our employees. Therefore, we request that all those joining our team are fully vaccinated against Covid-19.  Please do let us know if you would have any concerns around providing us with a record of your current vaccination status should you be successful in this role.

All eligible candidates are invited to apply. We respectfully ask for no agency approaches.

Please click here to apply.