12 remote jobs

The Senior Systems Engineer will be working with the product, platform, and software engineering team to provide design contr ol and software/systems development guidance. As a Senior Systems Engineer, you'll apply cutting - edge techniques and technologies, build great products, develop reusable platforms and grow great teams. You'll be a key technology and process leader at Orth ogonal and intimately involved in almost every aspect of a solution lifecycle from project inception, engineering design, implementation to maintenance and continuous improvement. These solutions include cloud - based applications, mobile, web, and web serv ices for the life science industry, and are used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment. Important aspect of the role: You're comfortable in a client facing role, being a technology leader as well as a team leader. What will...

Who are we looking for? Orthogonal is seeking a candidate for a Principal Software Engineer who will apply cutting-edge techniques and technologies, build great products and great teams that integrate devices, sensors, mobile and cloud computing. What will you do as a Principal Software Engineer? Given a vision for a product by the client, extract technical requirements that need to be addressed by a software and hardware solution Convert requirements into an architecture and design that will become the blueprint for the solution being created, and that supports a specific set of features Provide leadership in identifying, analyzing and responding to project risk Develop presentations, overviews and documentation that communicates the design to both the client and technical team members Assist in taking the design and converting it to raw epics that can be expanded upon and groomed into specific user stories utilized by the UX and development teams Participate...

This is a part time job for 10-20 hrs/week for 6-8 months with a potential to become full time. The applicant will be asked to help complete Kaya17's eQMS system and assist with completion of the DHF.  The ideal applicant will have had at least one year's experience working with QMS systems in a medical device (Diagnostics) company and will have a Bachelor's degree in a science or engineering subject.  The candidate will be asked to be on site at least one day in the week and will be an independently motivated individual with drive to accomplish the mission.  The position starts immediately.  The candidate should write a short cover letter along with their resume. 

CenterMed, Inc. is a medical device startup focusing on developing patient-matched maxillofacial surgical plans and accessories. We are looking for a Quality Engineer to join our CenterMed team! In this role, you will be working with other department partners to deliver safe and effective medical device designs for manufacturing, compliant with CenterMed policies and procedures. You will provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO13485, ISO 14971, 21 CFR Part 820. Job Responsibilities: Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained Executes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis Supports regulatory and...

Job description CenterMed, Inc. is a medical device startup based in the exciting bay area. CenterMed, Inc is determined and focused on developing patient-matched maxillofacial surgical accessories. We are looking for a R&D Engineer to join our CenterMed team.   ESSENTIAL DUTIES and RESPONSIBILITIES: ·      Design, develop and optimize patient-matched products ·      Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications ·      Develop test strategy based on design requirements derived from voice of customer, and execute protocol, testing, data analysis, and reports required for regulatory submissions ·      Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations ·      Create and update design control documents, including updating risk analysis...

Compliance Solutions is looking for a Senior Quality/Regulatory Consultant to help support all activities within the organisation. The role is homebased in the UK, with travel to clients sites when required. Key areas of responsibility:  Set up/Maintenance of technical documentation & design dossiers Undertaking US FDA 510(k)s, PMAs (Premarket Approvals), IDEs (Investigational Device Exemptions), Pre-Submissions and Designations Submission Regulatory submissions – global markets Support for the development of the company's regulatory planning, incorporating strategies for the product range in accordance with global requirements. Administrate regulatory dossiers to support product license applications, import license and product license maintenance for Regulatory Authorities Quality Management Support Solving regulatory questions on classification, technical files, device master records (DMRs). Device history records (DHRs). Design history files (DHFs), process...

Why TEAM? We are hiring! TEAM is seeking a Business Development Manager  to join our group in  Morristown, TN. Your main objective is to drive revenue growth for the organization through prospecting and winning new business as well as growing revenue organically with existing customer base. Responsibilities include developing strong relationships with prospects/customers, working with internal team to develop quotations, presenting quotes to customers, and negotiating to final sales. You "own" the customer and creates forecasts, communicates pricing initiatives and are involved with contractual reviews. About Us One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers.  With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer’s business. Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding...

Description Our client is a world leader in medical technology; offering innovative solutions in surgical instrumentation, neurosurgery, reconstructive, and general surgery for over 30 years. We are supporting them for a  Product Manager  to join their wound reconstruction team in a strategic position to help identify new product categories and additional clinical indications for existing product lines.  The right person will have an entrepreneurial spirit, great communication skills, great analytical skills and have the ability to provide strategic direction to the leadership team. We have helped 33 people join this client in the past 3 years including 3 on their marketing teams. The Right Talent: BS in Business, Marketing, Mechanical Engineering, Biology or related field MS or MBA preferred/strong business acumen and analytics experience 3+ years of experience with upstream marketing experience in Medical Device, Biotech or Healthcare Experience with market...

The Role We are looking for a talented Regulatory Affairs Lead to join our growing QARA Department at Kheiron. This is a really exciting role, reporting directly into our VP of Global Regulatory Affairs. This role will support our European and international expansion plans as we take our award winning AI products into new markets. You will work collaboratively across the organisation to guide and support the departments in what is needed for regulatory clearance and will have hands-on involvement in submissions.  We have offices in the UK, US, Hungary, and The Netherlands, and are open to candidate’s locations.  What you'll be doing:  Be responsible for completing the submissions, the technical files and other regulatory dossiers Support and implement regulatory strategy and oversee the execution of this roadmap Keep abreast of current regulations that affect our products Review labels, literature, collateral and claims as requested Provide regulatory...

Our Medical Practice Team is seeking a US-based business development professional to drive business in medical markets such as Lifesciences, Clinical Diagnostics, Medical Devices, and Digital Health. As part of our continuing business growth, we are expanding our team and adding this high-impact position combining business acumen, clinical understanding, and technical expertise.  If you combine clinical insight, relevant technical expertise, excellent critical thinking, and domain knowledge in key medical or life sciences technology areas then we would like to hear from you. You will be an ideal candidate if you have experience developing a pipeline of business in the medical or life sciences sectors for a services organization.  You have a deep understanding of technology, product development, and relevant market trends and are passionate about helping clients realize business transformation through technology. You are accustomed to working with both well-established...

At Greenlight Guru, our innovative software helps medical device companies focus on products that improve the quality of life for millions of people. Our innovative SaaS offering is revolutionizing how Medical Device companies invent, design, manufacture, sell, and support their products.  We have an exciting opportunity for a Quality, Security, and Compliance Engineer to join our Quality Assurance team.  You will be  responsible for strengthening the integrated Quality and Information Security Management Systems (QMS/ISMS) processes by employing best practices to ensure compliance to applicable standards, regulations, and internal policies  in a fast-paced, high-growth SaaS environment.  The Quality, Security, and Compliance Engineer will help the organization meet ISMS,  General Data Protection Regulation (GDPR), and California Consumer Privacy Account (CCPA) requirements. I mplement improvement initiatives while ensuring compliance with applicable new requirements and...