Process Engineer

SummaryElephas, a Madison, WI-based biotechnology start-up company, is seeking a highly motivated and creative Process Engineer. Applicants should be comfortable in a fast-paced and highly collaborative environment. The successful candidate will have hands-on experience executing verification and validation activities within a structured product development process.Essential Duties and ResponsibilitiesDraft and maintain verification and validation (V&V) documentation for instrumentation and manufacturing processesExecute verification and validation protocols for instruments and consumables, and summarize results in formal reports.Identify, document, and implement process improvements in collaboration with Manufacturing and Quality Control teamsSupport design control activities including the creation and review of risk management documents, test methods, and acceptance criteriaCollaborate with cross-functional teams to ensure smooth transfer of processes from development to manufacturingAssist in the investigation and resolution of non-conformances, CAPAs, and process deviationsWork in close collaboration with other team members to drive innovationEducation/Experience/SkillsBachelor's degree in life sciences, engineering, biotechnology, or a related field2-3 years of relevant industry experienceExperience working in an FDA (Class II/III) and/or ISO (13485) engineering environmentSolid understanding of design control processes and quality management systemsStrong analytical and problem-solving skills with a detail-oriented approach to documentationExperience managing or working with engineering tools and software such as 3D printers, CNC, and CAD software.We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.DISCLAIMERThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.