Project Engineer; Part Time

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.

• 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.

• 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).

• 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.

• 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.

Entry level

Part-time

Engineering and Information Technology