Seeking an entry-level Project Engineer (Focus: Regulatory/Clinical/Quality for Medical Devices) who can learn and become part of a seasoned consulting team. The role will provide quality support for companies in the medical device industry. This person should have experience in writing, organizing, and developing information for projects of a technical nature. Customer interaction is a key responsibility of this role and therefore strong communication and presentation skills are required.
In addition to the regulatory/quality support role, this role will also assist with technical writing and clinical research projects.
POSITION RESPONSIBILITIES
- Collaborate with clients and customers on developing and maintaining their quality management systems, SOPs, templates, and style guides based on industry and regulatory standards.
- Lead and participate in discussions, manage work product review sessions, and ensure client/customer comments are incorporated.
- Ensure work projects are delivered to the highest standard.
- Support clients in assigned project meetings and provide daily quality and regulatory guidance to ensure adherence with regulatory requirements as appropriate.
- Provide support to currently marketed products as necessary, including reviewing production records and quality system records to maintain compliance with quality and regulatory standards and regulations.
- In collaboration with clients and management, evaluate and recommend quality projects to support customers business objectives.
- Review and approve various regulatory and quality documents (i.e. technical documents, SOPs, Work Instructions, manuals, design reviews, risk management documentation, complaints, regulatory reporting documents, test protocols and reports).
- Work with clients to complete, maintain and document technical data and required quality and regulatory documentation.
- Develop, prepare, and submit technical documentation for US and International regulatory submissions.
- Execute quality aspects for any field corrective actions as required.
- Maintain up-to-date knowledge on domestic and international regulatory and quality requirements, and effectively communicate requirements to project teams and management.
- Proactively develop solutions to complex issues.
BASIC QUALIFICATIONS
- Bachelor’s Degree in Engineering.
- Experience working in a medical field a plus.
- Experience writing technical content.
- General knowledge with PC and MS Office (Word, Excel, PowerPoint, Outlook, and Adobe Acrobat).
DESIRED/PREFERRED QUALIFICATIONS
- Experience as a technical/medical writer.
- Experience in medical technology and/or software end user (consumer) documentation.
- Experience in producing documents and managing files in a controlled systems environment (workflow, permissions, versions, etc. are system controlled).
- Experience in the medical device or pharmaceutical industry.
- Aptitude to learn new product technologies, structured process development process.
- Excellent written and verbal communication skills.
- Self-motivated.
- Able to work independently and with teams.
- Demonstrated ability to meet deadlines and manage multiple priorities.
- Experience with creating and managing project schedules.
PHYSICAL JOB REQUIREMENTS
- This role will be part-time ~10 to 15 hours per week.
- The role is Remote so while performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
- The role will have no travel.
- Pay is $25 per hour paid monthly.
Seniority level
Entry level
Employment type
Part-time
Job function
Engineering and Information Technology
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