Pharmavise Corporation

QA Engineer

• Ensure compliance with medical device regulations
• Drive quality excellence across the product lifecycle
• Collaborate with R&D, Manufacturing, Regulatory, and Supplier Quality teams
• Support design control activities and risk management
• Conduct root cause investigations and manage CAPA processes
• Support internal, external, and regulatory audits

Quality Engineer

Engineer

• Lead and contribute to the end-to-end product development lifecycle, from concept and feasibility to design transfer and commercialization.
• Develop 3D models, detailed drawings, and engineering documentation using CAD software (e.g., SolidWorks, Creo) to support mechanical and electromechanical device design.
• Conduct design verification and validation (V&V) testing, analyze data, and generate technical reports that demonstrate compliance with applicable standards and requirements.
• Collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure design activities align with Design Control (21 CFR 820.30) and risk management standards (ISO 14971).
• Participate in risk analyses (FMEA, DFMEA, PFMEA), hazard assessments, and mitigation strategies throughout the product lifecycle.
• Support prototype fabrication, bench testing, and design iteration, translating test results into actionable design improvements.
• Work with Manufacturing Engineering to ensure Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) readiness.
• Prepare and maintain Design History File (DHF) documentation and ensure compliance with ISO 13485 quality system requirements.
• Support the design transfer process, including pilot builds, process validations, and technical documentation for production release.
• Contribute to continuous improvement initiatives, applying statistical methods, Lean, and Six Sigma principles to enhance design efficiency and product quality.

R&D Engineer

• Lead the planning and execution of medical device product development and commercialization projects from concept through launch.
• Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.
• Develop and maintain detailed project plans, timelines, resource allocations, and budgets.
• Ensure alignment between project goals and organizational strategy through effective stakeholder management.
• Serve as the primary liaison among R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.
• Manage change control processes and ensure that design and process changes are properly evaluated, documented, and approved.
• Identify potential project risks and mitigation strategies, maintaining proactive issue resolution throughout the project lifecycle.

Project Engineer

Product Designer

• Lead end-to-end UX/UI design for medical device interfaces, digital tools, and connected systems
• Develop user flows, wireframes, prototypes, and high-fidelity mockups
• Collaborate with Human Factors, R&D, Quality, and Regulatory teams
• Conduct user research, heuristic evaluations, and usability testing
• Translate user needs and risk analysis findings into traceable design documentation
• Design intuitive solutions for data-heavy environments such as dashboards, workflow tools, and device displays
• Partner with developers to ensure accurate implementation of design specifications

UX/UI Designer

Electrical Engineer

• Lead and execute electrical design verification testing (DVT) activities for implantable and external medical devices
• Develop and document test protocols, test plans, and verification procedures in compliance with quality and regulatory standards
• Perform bench testing using standard electrical engineering laboratory equipment (oscilloscopes, multimeters, function generators, etc.)
• Analyze and interpret test data; summarize findings and provide clear technical documentation
• Coordinate and track test investigations, ensuring timely completion and documentation accuracy
• Lead or support failure analysis and root cause investigations for test nonconformances and component issues
• Work closely with R&D, Quality, Manufacturing, and Systems Engineering teams to resolve technical challenges and ensure design robustness
• Support yield improvement activities, identifying and implementing process or design enhancements
• Maintain strict adherence to design control and quality system requirements, ensuring full traceability and compliance with FDA, ISO 13485, and IEC standards.

Administration

• Draft, review, and negotiate high volume of clinical study agreements
• Manage the end-to-end contracting process and coordinate with stakeholders
• Collaborate with Legal, Risk Management, Clinical, and Regulatory teams

Contract Administrator

• Draft and manage CAPAs, including conducting detailed root cause analysis
• Perform risk assessments, update Hazard Analyses, and maintain pFMEAs
• Produce clear, detailed, and accurate technical documentation
• Follow technical direction while independently contributing to project deliverables
• Collaborate with cross-functional teams (Quality, Regulatory, Engineering, Operations) to drive quality improvements
• Support a 6-week biomedical device project as a full-time remote contractor (40 hours/week)
• Start ASAP and deliver project-aligned quality systems work

Quality Engineer II – Biomedical Device

• Support application of design controls for projects focusing on design changes, material continuity, regulatory and standards compliance, corrective and preventive actions, and manufacturability/cost reduction.
• Ownership of design change projects including scoping, assessment, and implementation.
• Develop, update, and maintain Design History File and Design Input / Output documentation.
• Develop, update, and maintain risk management files such as Hazard Analysis, Task Analysis, and Design FMEA.
• Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet internal and external requirements.
• Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Build quality into all aspects of work by maintaining compliance to all quality requirements.
• Collaborate with cross-functional team (team of 5 Design Assurance engineers; total team of 20).
• Focus on imaging diagnostic catheter design changes.

Design Quality Engineer III, Medical Device

Project Manager

• Implement and support project management processes across core systems and M&A work
• Establish and maintain project performance metrics and measures; promote adoption and continuous improvement of standard project management practices
• Support project planning sessions, initiate new projects, and ensure timely post-project reviews
• Manage one or two process improvement or integration projects; own project plans, status reports, and deliverables
• Gather and document requirements and collaborate with multiple internal departments
• Consolidate and refine project status into program-level and senior management reports
• Drive process and requirement definition to facilitate selection and use of project management technologies
• Implement and support the use of project management and team collaboration technologies; support teams in Microsoft Office Suite use
• Build quality into all aspects of work by maintaining compliance to all quality requirements

Project Manager – Core Systems & M&A, Medical Device

• Implement and support project management processes; establish and maintain project performance metrics and promote adoption and continuous improvement of standard practices
• Support project planning sessions; work with project teams to set up and initiate new projects; ensure post-project reviews are completed in a timely manner
• Participate in portfolio and project status reporting
• Implement and support use of project management and team collaboration technologies
• Identify resources required for project activities and form teams to complete activities; build team commitment and ownership of project plans
• Execute projects timely; develop and monitor project scope, timelines, budgets, and spending
• Communicate priorities, risks and status to leadership team; provide input to functional managers on team/team member performance
• Foster a diverse workplace and monitor and ensure compliance with company policies, federal/country and regulatory requirements
• Build quality into all aspects of work by maintaining compliance to all quality requirements

Project Manager III, Medical Device

Full-stack Engineer

• Provide technical leadership to the team in software architecture and best in class software development methodologies and practices.
• Architect, design, develop and release innovative high performance medical device software.
• Solve difficult problems, improve state of the art, and achieve engineering excellence.
• Collaborate across disciplines effectively (HW, Systems, Test, Quality, Regulatory) to focus and maximize end-to-end solution value and quality.
• Participates in preclinical system experiments in the lab, with physicians, and 3rd parties.
• The Opal HDx Mapping System centers around a real-time virtual world of the human heart. As a physician probes the heart with a catheter, the system generates an accurate anatomical model of the chamber.
• High-performance rendering and algorithmic techniques are vital to creating a stunning view and providing the physician with instant feedback.
• Our technology includes C++ (C++11 or newer), Qt (Qt Widgets or Qt Quick/QML), Linux.
• The Principal Software Engineer will have a key role in the development of communication protocols for cutting edge medical applications in the field of Cardiac arrhythmia diagnosis and treatment.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements, e.g. Requirements, Design, and User Story documentation and review.
• Promote a collaborative environment and pragmatic engineering decision-making.
• Identify and implement continuous improvements to work processes and tools.
• May require limited travel.
• Schedule: 09:00 AM - 05:00 PM EDT
• Work Setup: Hybrid in Waltham, MA (minimum of 3 days per week onsite)
• May require limited travel.

Senior Software Engineer — Medical Device (Hybrid— Waltham, MA) Contract

• Lead software architecture and development of high-performance medical device software (C++, Qt)
• Architect, design, develop and release innovative high performance medical device software for the Opal HDx Mapping System
• Collaborate across disciplines effectively (HW, Systems, Test, Quality, Regulatory) to focus and maximize end-to-end solution value and quality
• Participate in preclinical system experiments in the lab, with physicians, and 3rd parties
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements, e.g. Requirements, Design, and User Story documentation and review
• Promote a collaborative environment and pragmatic engineering decision-making
• Identify and implement continuous improvements to work processes and tools
• Support field clinical staff on use of medical software and troubleshooting of issues
• Documentation: design specifications, test plans, and user manuals
• Preferred Qualifications: Linux platform experience, Scrum framework; IEC 62304, 60601, ISO 14971, 13485; Git, Jira, JAMA; strong learner and mentor

Principal Software Engineer, Medical Device

• Implementing and supporting project management processes; establishing and maintaining project performance metrics and measures, promoting adoption and continuous improvement of standard practices.
• Supports project planning sessions, sets up and initiates new projects, and ensures post-project reviews are completed in a timely manner.
• Involved in portfolio and project status reporting; implements and supports the use of project management and team collaboration technologies.
• Analyze current systems and procedures, identifying opportunities for enhancement; manage one or two process improvement or integration projects.
• Responsible for project deliverables, project plans, status reports, and gathering and documentation of requirements.
• Collaborate with multiple internal departments on a wide scope of PM and analysis efforts.
• Consolidate and refine project status into program-level and senior management reports; drive process and requirement definition for PM technologies.
• Support project teams in the use of Microsoft Office Suite and other technologies.
• Quality Systems: build quality into all work by maintaining compliance to quality requirements.
• Qualifications: 6-9 years with BA; 4-7 years with MBA; 1-2 years PM exp; Medical Device exp or highly regulated industry exp; PMP certification preferred