Program Manager

Company Description

Stratos MedTech Pty Ltd, a privately owned QLD-based startup, was created in 2023 to take award-winning women’s health system, PeriCoach, to the next level. PeriCoach was developed with the intention to treat the 1 in 3 women who suffer from incontinence through pelvic floor strength training.

Stratos has an established ISO 13485 certified manufacturing facility located in regional QLD. Stratos' strategic focus is on maintaining the PeriCoach's reputation as The Clinician's Choice through its extensive clinical evidence, high quality manufacturing processes and innovative product development. Patented technology and design registrations as well as regulatory clearances in all major regions place PeriCoach as the leader in this space. First released in 2014, it is ahead of the curve for real-world-evidence generation.

Role Description

This is a six-month part-time remote contract for a Program Manager, in a startup organisation in the medtech sector. The opportunity is a multifaceted, highly practical role that will suit an individual with a proven history of product design, manufacturing and supply chain experience.

The Program Manager will be responsible for overseeing the planning, implementation, and tracking of multiple projects within the organisation. They will collaborate with cross-functional teams to ensure project goals are met on time and within budget. The Program Manager will also be required to assist in maintaining regulatory compliance, achieve quality objectives and participate in manufacturing planning and execution. Would suit an engineer with experience in manufacturing. This is a very multi-disciplinary role requiring a driven self-starter; someone who can use their initiative to construct their own roadmap for the role, and execute their day to day in accordance with it.

The role is a flexible 25-30 hours per week (negotiable), working from home with an occasional site visit (perhaps once per month) in regional QLD (Maryborough). Approx 5% travel to suppliers as needed. Candidate preferably located in QLD but must reside in Australia.

You will be responsible for (but not limited to):

• Assisting in the implementation of regulatory strategies for existing product, including continued compliance with the FDA's Quality Systems regulations, GMPs, ISO13485 and other local and international regulatory requirements;
• Assisting in the maintenance of our ISO 13485 quality management system
• Participating in root cause analysis and taking corrective and preventive actions for product and process issues, including internal and external audits as necessary;
• Maintaining technical files
• Interfacing directly with contractors in a professional manner
• Producing project-related documentation
• Manufacturing activities, including testing, monitoring quality, raising NCPs / CAPAs etc
• Managing suppliers

Qualifications/Skills

• Project Management, Program Management
• Experience in manufacturing
• Strong leadership and team management abilities
• Excellent communication and interpersonal skills
• Problem-solving and decision-making skills
• Ability to prioritize and multitask effectively whilst working on multiple projects at the same time
• Excellent attention to detail
• Knowledge of healthcare industry regulations and standards
• Bachelor's degree in engineering preferred
• A minimum of 2 years experience in a related industry, including at least 1 years experience in the medical device industry.
• Experience working within a QMS - specific experience with ISO 13485, ISO 9001 a plus
• Strong project management and problem-solving skills
• Ability to learn new things
• Willingness to travel to suppliers as needed
• Self-motivated with an ability to work independently in a small team
• Experience in product development a plus

What do we offer?

• Exposure to a range of tasks across the organisation. Gain experience in multiple key areas
• Competitive remuneration package is on offer, in line with qualifications and experience
• Training as required
• Flexible working arrangements
• Dynamic startup environment
• A shared mission to improve women's quality of life