Head of Hardware Development

SIME seeks a flexible, entrepreneurial individual who is passionate about making a difference to patient outcomes and who thrives on assuming a leadership role in a rapidly evolving SME environment. While SIME is based in London, the company is willing to consider candidates from diverse geographies. The company will offer an attractive package including stock options.

The successful candidate will lead development of SIME’s next-generation technology hardware platform, and will also play a leading role in SIME’s ongoing transition to an ISO13485-compliant development process.

More information

Applicant Requirements

The ideal candidate will have an appropriate mix of the following experience:

• Bachelors and/or Masters level degree in engineering, physics or a related discipline

• A minimum of 10 years’ IVD industry and medical device R&D leadership experience, including a track record of successful medical product development

• Significant project and management experience in a commercial stage medical device or pharmaceutical organisation

• Successful track record of delivering medical technology product development programmes in an ISO13485/9001 and FDA CRF 21/820 and GMP-compliant environment

• Track record of successful vendor and supply chain project management, including of major outsourced product development programmes

• Demonstrated success with transition of medical technology into manufacturing environment, including relevant experience selecting & managing contract manufacturers

• Significant hands-on technical experience in clinical laboratory and analytical technologies, ideally including FTIR spectroscopy, mass spectrometry, molecular biology, immunoassay and/or biochemistry techniques

• Knowledge of, and/or direct experience with, clinical sample preparation and processing technologies

• Relevant mix of experience of IoT, cloud computing, data science, machine learning, artificial intelligence, embedded systems, calibration and/or IoT / edge systems • (Ideally) Familiarity with development of embedded medical firmware & decision support software to IEC62304/82304 and other applicable international standards

• (Ideally), experience implementing medical technology quality management systems

• Strong communication skills; able to present compelling vision to internal and external stakeholders

Role, Location and Salary

POSITION: Head of Hardware Development

REMUNERATION: Compensation (including equity) commensurate with experience

PLACE OF WORK: UK flexible, with significant travel to London, Edinburgh, Denmark, US and China

EMPLOYER: British/Danish Diagnostics Company

DURATION: Full time (with 3-month probation) HOURS OF WORK: 5 days week (7.5 hours/day)

REPORTING LINE: Directly to the CEO and eventually to CTO

LANGUAGE: The company’s working language is English and a strong command of both spoken and written English is essential.

Diversity

SIME is committed to make diversity and inclusion part of everything we do – from how we build our products to how we build our workforce. Founded on the principle of improving health for all gives us an elevated level of responsibility in everything we do. Including building a workforce that is passionate about inciting positive change and a workplace that creates a sense of belonging for everyone.

contact careers@simedx.com to apply

No recruiters please

Chief Clinical Officer

SIME seeks a Chief Clinical Officer to take ownership of the company’s clinical development strategy initially in Europe, USA and China, The successful candidate will be a key member of SIME’s leadership team and will play a vital part in the further development and clinical deployment of a technology that is saving the lives of infants across the world, whilst also saving hospitals the high costs of patient morbidity and mortality.

While SIME is based in London, the company is willing to consider candidates from diverse geographies. The company will offer an attractive package including stock options.

More information

Key Responsibilities

• Providing oversight, leadership, and guidance in the management and execution of clinical research & development

• Ensuring clinical development objectives align with company commercial strategy

• Ensuring clinical, operational and medical governance excellence across all clinical development projects 

• Serving as the main point-of-contact for US and international respiratory-medicine experts to foster and develop credible working relationships of high value

Applicant Requirements

The ideal candidate will have an appropriate mix of the following experience:

• Medical degree or advanced degree in life sciences, medical technology or allied field

• 15+ years experience in clinical program management, clinical development strategy and study design/trial management and reporting

• (Ideally), knowledge of neonatal medicine and/or critical care (NICU/ICU) product development

• (Ideally), experience base including clinical decision support technologies, clinical diagnostics and clinical informatics

• Working knowledge of Health Economic and Outcomes Research (HEOR) practices.

• Demonstrated scientific credibility, and ability to input and influence projects through scientific and operational expertise; proven ability to interpret complex clinical data

• Detailed knowledge of international regulations governing clinical research of medical devices • Familiarity with ISO13485 Quality Management System development environments

• Competency in data analytics to further SIME development and clinical research strategies.

• Project and management experience in a commercial stage medical device or pharmaceutical organisation

• Successful track record of delivering medical technology programme management in an ISO13485/9001 and/or FDA CRF 21/820 and GMP-compliant environment

• Strong communication skills; able to present compelling vision to internal and external stakeholders

Role, Location and Salary

POSITION: Chief Clinical Officer

REMUNERATION: Compensation (including equity) commensurate with experience

PLACE OF WORK: UK flexible, with significant travel to London, Edinburgh, Denmark, US and China

EMPLOYER: British/Danish Diagnostics Company

DURATION: Full time (with 6-month probation)

HOURS OF WORK: 5 days week (7.5 hours/day)

REPORTING LINE: Directly to the CEO

LANGUAGE: The company’s working language is English and a strong command of both spoken and written English is essential.

Diversity

SIME is committed to make diversity and inclusion part of everything we do – from how we build our products to how we build our workforce. Founded on the principle of improving health for all gives us an elevated level of responsibility in everything we do. Including building a workforce that is passionate about inciting positive change and a workplace that creates a sense of belonging for everyone.

contact careers@simedx.com to apply

No recruiters please