Job Description

About Curve Tomorrow

Curve was founded in 2009 and has been run for the last several years by Moh, George and Sanji - three Melbourne University alumni with a shared dream of starting an impact lead company. Like all start ups, Curve has been through peaks and troughs - but we've never stopped learning or stopped focusing on how we can use digital technology to transform lives.

At Curve, we bring science to innovation, enabling your health organisation to become an iconic leader. We both consult and create; we can help you find and analyse opportunities or we can create the concepts to meet the opportunities.

Our mission is to impact 1 billion lives through transformative health technology solutions

Curve goes beyond the ideation, systems and governance components of innovation into concept development, prototyping, productise and commercialisation. Our rapid prototyping capabilities allow us to design, develop and test concepts in cycles well ahead of market launch.

Position Description

Curve Tomorrow is dedicated to impact looking for talented and motivated individuals to join our growing team.

The Design Quality Engineer will work in collaboration with a global team based in Australia, India, Netherlands and Pakistan in a cross-functional team environment. Collaborates with Curve Tomorrow teams on providing awareness of Medical Device standards & regulations - ISO 13485, ISO 14971, IEC 62304, SaMD, IEC 82304, CE, 21 CFR 820 - Design Controls, 510(k), MDR, TGA ARGMD and others as required. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Core values must include commitment to excellence with demonstrated ethics and integrity.

Curve is looking for

• Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure project completion with regulations and expectations met.
• Persuasive influencers: People who understand market positioning and can use their relationship skills along with their depth of knowledge to secure cooperation, loyalty and collaboration of their engineering partners.
• Smart-working partners: People who uses new technologies and the development of existing technologies to improve both the performance and the satisfaction from the job.

• Primarily responsible for Risk Management, reviews of Design control deliverables - Design input & output, Design History File documents review.
• Work with team to develop robust SW architecture as per Quality and Regulatory requirements.
• Work with team to develop robust verification, validation and release strategies to ensure SW product compliance, safety, reliability and effectiveness.
• Working knowledge of current industry standards for SW engineering and Risk Management practices.
• Demonstrated ability to apply SW and sytem quality management practices in efficient and effective ways while being compliant.
• Provide solutions based approach to quality engineering.
• Collaborate with SW engineering team and drives the implementation of SW Development processes of Curve QMS for the projects developed at Curve Tomorrow and Weguide.
• Supports the engineering and QMS teams during audits (internal and external).
• Drives GxPs - Good Documentation practices, Good Clinical Practices, etc.; as per organizational requirements.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal procedures to assure compliance for QMS.
• Drive process compliance in the complete lifecycle process of the medical device, mainly Software.
• Collaborate and consult product team members in implementing and realizing the processes.
• Collaborate and coordinate with cross functional team to review technical documents.
• Ensures product compliance with legal and normative requirements.
• Drive best practices within the organization

• Bachelors or Master's in Computer Science / IT / Biomedical / BTech / MCA with 2-4 years experience in QMS.
• Experience in the Healthcare industry - Medical Device software is an additional advantage.
• Working knowledge of Quality Management systems - ISO 13485 / ISO 9001 / ISO 27001 / US FDA / GxP requirements.
• Knowledge of Risk Management as per ISO 14971.

• Good understanding of Software Development Life Cycle and Agile methodology.
• Knowledge and understanding of Agile methodology is an advantage.
• Knowledge on Computer system Validation as per FDA guidance.
• Good documentation and communication skills.
• Good understanding of Software Development Life Cycle and Agile methodology.
• Tools - Confluence, Comala, Jira, etc.

• Excellent communication, presentation and interpersonal skills with proficiency in English (verbal & written)
• Ability to operate independently and as part of a team. Good team player.
• A positive attitude, innovative and creative thinker.
• Structured and have a process-driven mindset.
• Good analytical skills and problem-solving skills.
• Willing to accept stretch goals and challenging deadlines.