Company DescriptionPECA Labs is a Pittsburgh based medical device manufacturer within the cardiovascular space with both vascular graft and valve products.
Role DescriptionThis is a full-time on-site role for a Medical Device Product Development Manager at PECA Labs in Pittsburgh, PA. The Research and Development Manager will be responsible for overseeing the research and development activities, leading a team of researchers, managing projects, and ensuring the successful execution of R&D initiatives.
QualificationsProven experience in a research and development roleExperience in a management role within the medical device or related industriesStrong leadership and project management skillsExcellent problem-solving abilities and analytical skillsEffective communication and team collaboration skillsProficiency in data analysis and interpretationExperience in product development and innovation
PECA Labs is a Pittsburgh based medical device manufacturer within the cardiovascular space with both vascular graft and valve products.
Position will requireMaintain and grow company's ISO 13485 and FDA-Compliant Quality SystemOversee and manage small quality and regulatory teamDevelop strategies for regulatory approval and introduction of new products to marketManage the process from development of regulatory strategies through to approvalPrepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approvalsEnsure that all regulatory-related policies and procedures are current and in accordance with applicable regulations and standardsProvide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirementsEstablish appropriate risk analysis activities, which include the use of risk analysis toolsProvide updates on regulatory requirement changes, which affect individual product specifications or quality systemsEstablish solutions to regulatory problems by utilizing novel approaches when requiredFoster collaborative, efficient and effective working relations with regulatory authorities such as the FDAUnderstand and implement export/import regulation
Job SummaryThe Assembly Technician is responsible for the assembly of and boxing of company's medical devices. This role entails the assembly of plastic components from work instructions to form cardiovascular conduits.
Key Job Responsibilities:Assembly of plastic conduitsAbility to follow specific manufacturing guidelines and protocolBoxing of assembled devicesInspection and verification of completed devicesAccurately maintain forms and paperworkAbility to follow cleanroom protocols
QualificationsRequiredHigh School Diploma or equivalentAbility to lift up to 50 pounds3 years related work experience
Preferred3 years related experience with vocational or further educational training related to electrical engineering technology
