Design Control & Formulation Engineer

Clyra Medical is a growth-stage medical device company developing innovative wound care solutions to improve patient outcomes globally. This is a high-impact role within Clyra’s Innovation & Development Unit – sitting at the intersection of technical documentation and product development – offering the opportunity to build the compliance infrastructure that brings innovative wound care products to market while contributing directly to R&D activities in the lab.

The Design Control & Formulation Engineer is primarily responsible for building and maintaining the technical documentation infrastructure that underpins Clyra’s regulatory compliance and product development activities — including SOPs, design control records, validation protocols, test methods, and DHF/DMR/DHR maintenance — while providing hands-on support for formulation and chemistry work in the lab under the direction of the CSO.

The ideal candidate is an exceptional technical writer with a strong science foundation who is comfortable at the bench and understands how rigorous documentation drives FDA and ISO compliance. This role reports to the Chief Science Officer, with a dotted line to the Vice President – Product Operations

Duties and Responsibilities:

Technical Documentation & Document Control

• Author, maintain, and own the review and approval lifecycle of core technical documents including work instructions, batch records, test methods, product specifications, verification and validation protocols and reports, and change controls.
• Author and maintain of design control documentation, including design inputs and outputs, design history files (DHF), device history records (DHR), device master record (DMR) and product traceability documentation in compliance with 21 CFR Part 820 and ISO 13485.
• Author and maintain design and process FMEA, hazard analyses, and risk management files; ensure documentation reflects current product and process state.
• Author and maintain protocol documentation for design verification and validation activities; ensure protocols are complete, traceable, and audit-ready prior to execution.
• Work within the document control system (currently Greenlight Guru), ensuring documents are current, version-controlled, and accessible to relevant personnel.
• Support preparation of technical documentation packages for regulatory submissions and audit activities under the direction of the Quality team.
• Support cross-functional staff with documentation questions, procedures, and training.

R&D & Product Development Support

• Support and execute assigned formulation and product development activities, including liquid and gel formula preparation, basic wet chemistry testing, and stability studies under the direction of senior R&D staff.
• Provide documentation support across the stage-gate development lifecycle, ensuring complete and compliant documentation at each phase gate.
• Assist with test method development and validation; document results with precision and in compliance with applicable procedures.
• Support design transfer activities to manufacturing, including documentation of hands-on quality control activities from bench through pilot scale-up.
• Perform routine testing and maintenance of R&D lab equipment; document calibration and maintenance records in accordance with applicable procedures.
• Contribute to product lifecycle analyses to support innovation, performance improvement, and cost-reduction opportunities.

Raw Material & Supplier Documentation

• Contribute to raw material specifications, packaging specifications, and supplier qualification documentation under the direction of senior staff.
• Maintain accurate raw material and packaging specifications and supplier qualification documentation; provide documentation support to the Quality team on supplier-related activities as needed.

Cross-Functional Collaboration & Communication

• Collaborate actively as an integrated member of the Quality, Regulatory, Manufacturing, and Contract Manufacturing teams, contributing to the resolution of technical documentation challenges and supporting seamless design transfer.
• Participate in risk management meetings and contribute to verification of risk mitigation implementation in products and processes.
• Keep management and senior team members informed of project status, documentation progress, and technical issues.
• Stay current on applicable FDA, ISO, and international regulatory standards to support ongoing compliance and best-practice documentation.
• Other duties as assigned.

Required Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Biochemistry, Biomedical Engineering, Life Sciences, or a related discipline.
• 3–5 years of experience in a regulated medical device, combination product, or life sciences environment, with demonstrated ownership of technical documentation.
• Proficiency in authoring and managing technical documentation: SOPs, test methods, batch records, validation protocols and reports, design control records, and change controls.
• Experience with design control documentation including DHF, DMR, DHR, FMEA, and risk management files in compliance with 21 CFR Part 820 and ISO 13485.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience working within a document control system or QMS platform.
• Working familiarity with wet chemistry fundamentals — including liquid and gel formula preparation, pH adjustment, titration, and basic laboratory procedures — sufficient to author accurate test methods and batch records and to support bench work alongside senior R&D staff.
• Strong technical writing skills with exceptional attention to detail.
• Collaborative team player who thrives in a fast-paced, growth-stage environment.
• Strong interpersonal and communication skills; comfortable engaging with cross-functional teams.