EnMovi is an exciting, newly formed digital therapeutics, orthopaedic technology company, based in the US. EnMovi has multiple offices in Glasgow and London with over 25 employees worldwide. The main focus of the company is launching a set of wearable sensors to gather data about the rate of recovery after knee operations, known as 'Motionsense' and 'OrthoLogIQ'. Both technologies have the capability to monitor the patient's journey pre, intra and post-operatively, empowering surgeons and patients with comprehensive data-driven solutions.
The Systems Engineer will be a part of the team responsible for the research, design, development, and sustaining engineering of electro-mechanical medical devices and associated sterile disposable products that meet the highest standards for accuracy, safety, and operating functionality. The primary responsibility is to support the implementation of design controls and maintain the Design History File for our products. Responsibilities:
Qualifications and Skills:
- Requirement elicitation, and management.
- Creating, Drafting and Maintaining, validation and traceability reports. Assessing if the outcomes meet user and product requirements.
- Ensuring design files are created, maintained and structured to adhere to company policies.
- Updating QA, Design and Validation documentation and maintaining risk register for the product(s) in line with any documented changes.
- Create and Maintain Risk Management deliverables per ISO 14971 including risk management plans, risk analysis documents (design FMEA, process FMEA, use FMEA), risk management reports, and risk reviews.
- Ensure compliance to FDA 21 CFR 820.30 - Design Controls - for the product(s).
- Conduct and document design reviews and peer reviews, providing feedback regarding whether designs meet requirements at the system and component level based on analyses.
- Creation and maintenance of Design History Files.
- Create and route ECOs (change orders) for controlled documents.
- Support Regulatory and Quality Team during external agency audits and internal quality system audits.
- Supports Regulatory and Quality Team during CAPA, Complaints and Post Market Surveillance Investigations.
- Supporting Manufacturing and drafting required reports such as IQ, OQ, PQ and MWI.
- Adhere to EnMovi's standard operating procedures.
- B.S. in Engineering or Scientific discipline.
- 4+ years within Quality Assurance or Quality Control within an FDA regulated environment (Medical Device preferred or regulated industry).
- 2+ years specifically within Design Control and Risk Management.
- Strong understanding of FDA GMP regulations (21 CFR 820).
- Working Experience of 60601 and 14971.
- Strong understanding of ISO 13485.
- Training in systems engineering principles preferred.
- 4+ years of Product Development experience preferred.
- State of the art IT equipment.
- Annual bonus scheme.
- IP creation patent bonus.
- Private healthcare plan.
- 25 days holidays.