Biomedical Engineer – Voice Restoration Medical Devices

Biomedical Engineer – Voice Restoration Medical Devices

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Employer

Laronix Pty Ltd

Location

Level 9, 167 Eagle Street, Brisbane QLD 4000

Website

https://www.laronix.com/

Employment

Full-time, permanent – 38 hours per week

Hours

Full-time, 38 hours per week.

About Laronix

Laronix is an Australian deep tech company that develops and commercializes medical devices for voice restoration. The company operates under an ISO 13485 certified quality management system and develops breakthrough voice restoration medical products for people suffering from voice loss. The company’s technology developments cover the full range of new product development from early-stage prototyping through design release, regulated manufacture and commercial supply.

Role overview

Laronix is seeking a qualified Biomedical Engineer specialising in the R&D, design, development and manufacturing of patient-interfacing voice-restoration medical devices. The role covers design concept development, prototyping, verification and validation, design transfer, manufacturing support, coordinating technical aspects of product quality management, and assisting commercial product release under strict requirements of ISO 13485.

Required qualifications, skills and experience (must have)

The successful candidate must have substantial hands-on experience spanning New Product Development (NPD) including:

· A minimum of three years in design and development of patient-interfacing medical devices with preferred focus on respiratory, airway, speech or voice-restoration technologies.

· Established skill set in new medical device design and development skills in CAD and/or mechanical design in a commercially focused setting.

· A minimum of two years’ experience in Digital Light Processing (DLP) prototyping and regulated manufacturing transfer.

· A track record of contribution to at least one new medical device, designed, developed and commercialized (with evidence of sales) in the last 3-5 years.

· A track record of active contribution to design, development and manufacturing of at least one FDA-registered or FDA-listed medical device in the last 3-5 years.

· A track record of active contribution to quality management development and ISO 13485 design controls in a medical device company with at least two successful notified body ISO 13485 audits in the last 3-5 years.

· A minimum of two years’ solid experience or established knowledge with speech, sound and acoustics in the context of wearable electro-acoustic products (preferably artificial larynx products).

Key responsibilities

Main Duties & Responsibilities

As the Biomedical Engineer – Voice Restoration Medical Devices, you will be responsible to deliver projects involving design, development, and manufacturing of Laronix – Voice Restoration Medical Device products which can be in different stages of development from research to commercial devices. Your role requires close involvement in the technical aspects of design and manufacturing these products which includes design and testing cycles of these products as well as their manufacturing process.

Some of our design and manufacturing is performed in-house but some of these, including electronic designs, are occasionally outsourced. You will be responsible for the design and development and manufacturing process whether in-house or outsourced is consistent with Laronix’s product specs, usability strategy, quality management system, regulatory, project budgets and timelines and corporate governance frameworks.

Your roles and responsibilities may change within this general framework from time to time. You may be assigned by the Employer to collaborate with the Laronix Team on projects or product designs that are led or managed by other team members.

Without limitation, your role and responsibilities as the Biomedical Engineer – Voice Restoration Medical Devices at Laronix include (but is not limited to):

New Medical Device Product Design and Development

· Design, R&D, develop and release mechanical and biomedical components for patient-interfacing voice-restoration devices (including artificial larynx devices) by applying engineering principles to respiratory airflow, sound generation, acoustic performance, mechanical design principles, build tolerances, medical compliant materials and patient usability and safety.

· Working with Laronix team and/or external designers to design any new systems, and commercially viable products or develop existing or novel technology within project’s time and budget.

· Coordinating design projects from concept to minimum viable products (MVPs) to commercial products manufacturing through cycles of design and usability testing.

· Delivering, or performing any aspects of design and development including design planning, product scopes, design reviews, verification, and validation.

· Coordinating or managing external suppliers or contractors of Laronix projects.

· Defining and coordinating design projects or product scopes including planning, component selection.

· Working with Laronix Team and external contractors to create and present proof of concept, MVPs or commercial designs, for all new devices in line with regulatory and quality requirements, product risk assessment, and safety requirements.

· Working with Laronix team to deliver projects’ agreed milestones in a timely manner.

· Support verification and validation activities under an ISO 13485 quality management system.

· Ensuring that a product can be made again reliably and will perform consistently in specified operating environments including medical devices.

· Keeping up to date and training the team about developments in medical devices, and manufacturing technologies, quality management and regulations.

· Ensuring product design complies with Medical Device Regulations (e.g., FDA, TGA, ISO 13485) standards, technical requirements and standards (EMC compliance, IEC 60601) as well as other international medical regulations.

· Identifying opportunities for future product direction, improvement, and enhancement.

Product Usability and Testing

· Working closely with Laronix’s Product Team to develop, and implement user insights into the design of novel and existing products.

· Responsible for taking products through multiple rounds of testing and improvements, ensuring compliance with quality systems and standards.

· Responsible for technical aspects of usability testing of Laronix products prior to and post commercialization.

· Work closely with Laronix’s senior management to analyze, and test any Laronix products against design requirements and produce design documents, specifications, estimates, and plans.

· Ensuring that a product will function based on design requirements based on extensive usability testing and is compatible with industry standards.

· Coordinating product testing, analyzing and developing test requirements based on user insights, implementing test methods and design and testing specifications, estimates, and plans.

· Working closely with Laronix’s Product Team to systematically test the products against design requirements and user feedback to ensure the product meets the usability and design requirements.

· Systematically improving the detailed design working with external and internal designers based on usability testing data in Verification and Validation Cycles.

· Defining test protocols and following and coordinating the product and usability teams to ensure the products stand out in meeting the usability and design requirements.

Quality Management Development and Regulatory Compliance

· Direct contribution to the technical aspects of Laronix’s Quality Management System development and ISO 13485 compliance.

· Prepare required design documentation to include Laronix new products in Laronix’s QMS system.

· Following documents produced by other engineers/quality systems staff and other employees within the approved document control system.

· Systematically improving the detailed design.

· Prepare for and participate in BSI notified-body audits, maintaining the engineering and quality evidence required for successful audit outcomes.

· Maintain controlled design documentation, revision records, design changes and manufacturing traceability.

Rapid Prototyping and DFM Support

· Coordinate a small to mid-sized manufacturing team supporting regulated medical-device production.

· Coordinate external design consultants, prototype suppliers, contract manufacturers and production manufacturers.

· Investigate design, production and nonconformance issues and implement controlled corrective or design changes.

· Working with Laronix Team for rapid prototyping samples while complying with company quality processes and (medical devices) regulatory guidelines.

· Support the end-to-end manufacturing of quality products, ensuring that production stays on schedule, and manufacturing/production problems are resolved.

· Supporting Laronix’s design team for the Design for Manufacturing (DFM), preliminary Verification and Validation of the DFM with patients and having the DFM approved by the external manufacturer.

· Plan and manage rapid-prototyping activities using Digital Light Processing (DLP) systems and medical-grade materials, including print-parameter selection, post-processing, dimensional verification and prototype troubleshooting.

· Assess and coordinate the transition from rapid prototyping to repeatable controlled manufacturing processes, including manufacturing specifications, tolerances, inspection requirements and production documentation.

Manufacturing/Technical Support

· Collaborating with industry partners in connection with Laronix’s Manufacturing Team to agree and set up requirements for manufacturing approach / method / machinery.

· Coordinating technicians, craftspeople, and other colleagues for design, design transfer and manufacturing.

· Setting up and ensuring compliance with requirements for manufacturing approach / method / machinery.

· Working in compliance with approved quality standards, mainly ISO 13485 and GMP.

· Documenting all design and development processes.

· Writing of specifications and technical reports in accordance with Medical Device Regulations (e.g., FDA, TGA, ISO 13485) standards as well as other international medical regulations.

· Ensuring that all documents are written using clear and concise language and are up to date.

· Ensuring that documents meet all relevant specifications and are compliant with the project brief and internal company requirements, policies/procedures.

Project Product Delivery and Coordination

· Support commercial product-release activities by preparing and maintaining engineering documentation required for regulated release and TGA or FDA device registration/listing activities, as applicable.

Skills, experience and capability (must have)

· Minimum Bachelor of Biomedical/Medical Engineering.

· New Product design and development (design change control and versioning) from concept to post product launch and design maintenance.

· Commercial delivery of at least one new FDA regulated New Product Design (NPD) released and sold in the market in the last 3-5 years.

· Strong experience with design, development and manufacturing of at least one new product, in the last 3-5 years.

· Minimum three years’ practical experience working within an ISO 13485-certified medical-device quality management system.

· Minimum three years’ practical experience applying medical-device design controls, verification and validation, document control, change control, nonconformance investigation and manufacturing traceability.

· Minimum three years’ experience supporting external ISO 13485 certification, surveillance or recertification audits, including participation in at least two successful external audits within the previous three years and responsibility for audit preparation, objective-evidence management and direct audit participation.

· Minimum two years’ advanced hands-on experience with Digital Light Processing (DLP) additive manufacturing for medical-device prototyping, including medical-grade photopolymer materials, print-parameter selection, post-processing, dimensional verification and prototype troubleshooting.

· Minimum two years’ experience transitioning biomedical-device components from rapid prototype manufacture to repeatable controlled production, including tolerances, manufacturing specifications, inspection requirements and production documentation.

· Minimum three years’ professional SolidWorks experience in complex 3D part and assembly modelling, production drawings, DLP/SLA prototyping and Design for Manufacture and Assembly (DFMA).

· Demonstrated experience transitioning CAD designs into controlled production, including revision control, engineering changes and manufacturing documentation.

· Strong experience with New Product Design (NPD) in medical field released and sold in the market in the last 3-5 years.

· Project Management and Documentation platforms (Confluence/Jira).

Application

Please submit a current resume and a brief cover letter describing how your qualifications and experience meet the required criteria. Applications will be assessed against the genuine requirements of the position.

Proposed deletion from existing advertisement:

Citizens and Permanent Residents will be preferred. Other applicants with full work rights can apply only if they meet the above criteria.

Pay: $90,000.00 per year

Application Question(s):

• Do you have strong experience with design, development and manufacturing of at least one new product in the last 3-5 years
• Do you Commercial delivery of at least one new FDA regulated New Product Design (NPD) released and sold in the market in the last 3-5 years?

Education:

• Bachelor Degree (Hons) (Preferred)

Experience:

• ISO 13485-certified medical-device quality management system: 3 years (Required)
• biomedical engineer: 3 years (Required)
• Solidworks Designer: 4 years (Required)
• Clinical Audit: 3 years (Required)
• Rhinoceros 3D: 5 years (Required)
• Digital Light Processing (DLP): 3 years (Required)

Work Authorisation:

• Australia (Required)

Work Location: In person

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