Silk Road Medical is hiring! We are looking for candidates to join our team for the following positions:
Therapy Development Specialist/Clinical Specialist (Texas- Dallas or Houston)
Summary: The Therapy Development Specialist is an entrepreneurial ambassador for a new hybrid procedure to treat carotid artery disease: TCAR (TransCarotid Artery Revascularization). As part of the new commercial field team he/she will lead the next revolution in endovascular surgery to execute market development and therapy adoption initiatives in TCAR Centers of Excellence, prospect new commercial opportunities, become a trusted clinical partner and TCAR specialist to drive safe adoption, superior outcomes and achieve sales revenue targets of the ENROUTE Transcarotid Neuroprotection System, ENROUTE Transcarotid Stent System and related products. The Silk Road Medical Therapy Development Specialist practices excellent relationship management with customers, with strong organization, administration and expense planning and control. The Therapy Development Specialist is a partner and resource to the SRM cross functional teams, including Sales, Field Clinical, Professional Medical Education, Marketing, Research and Development.
Basic Position Qualifications:
- Bachelor’s Degree
- 5+ year’s sales and/or clinical experience in a hospital environment; selling into minimally invasive cardiovascular market, EVAR/TEVAR, TAVR, peripheral or surgical related products.
Human Resources Manager
Summary: The Human Resource Manager guides and manages the overall provision of human resources, policies, and programs for the Company
- Payroll preparation and payment, vacation accrual, commission payments through ADP
- Expense reporting tracking, auditing and payment through Concur
- Set up and manage state tax jurisdictions for payroll and other, ensuring all applicable taxes are paid on a timely manner
- Recruiting and staffing
- New hire orientation and enrollment forms
- Benefits maintenance, including health, vision, dental, 401k and flexible spending plans
- Annual performance reviews and goal setting
- Compensation tracking and assessment
- Vendor credentialing and background checks
- Assist with periodic accounting audits in the personnel area
Office & Finance (help as needed)
- Assist with facilities, space planning and potential Company moves
- IT backup for employee requests and issues
- Assist with accounts payable, accounts receivable and maintenance
- Contracts, vendor and customer maintenance
- Assist sales operations and customer service when available
- 5 years’ experience in human resource role with general business preferred
- QuickBooks experiencey
- ADP payroll experience
- Preferred experience: facilities management, customer service and sales operations (salesforce.com), IT and office management
Sr. Manufacturing Engineer
Summary: The Senior Manufacturing Engineer will develop and improve processes and equipment to facilitate the manufacture of new, redesigned, and current products that will meet established specifications and will conform to established cost limits. Continuous engineering and design enhancement of existing products. Support in new product/process development.
- Production support– Evaluates and develops innovative solutions to complex product and production problems through identification and implementation of advanced manufacturing processes including conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, automation and materials.
- Product Quality – Support continuous improvement and design enhancement of current products to improve quality and cost. Ensures proper documentation is completed to meet quality systems requirements.
- Product Design – Provides Design for Manufacturability (DFM) input and contributes to overall design project working team.
- Quality Systems – Support the ISO, EN, and MDD certification process and compliance to FDA regulations by ensuring compliance to all applicable policies, procedures and guidance documents during the discharge of assigned tasks and duties.
- Production infrastructure– Analyzes and plans work force utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency. Evaluates line efficiency, cycle time, and TAKT time.
- Validation and Qualification support -Defines execution of Equipment Qualification and Process Validation Protocols (IQ, OQ, PQ) and provide training for Production Team Members on Standard Operation Procedures and Work Instructions for new processes and equipment
- Corrective and Preventative Action – Participates in development of corrective and preventative action plans.
- Metrics Analysis And Reporting – Executes engineering and quality methods analysis including FEA, Tolerance Analysis, DOE, SPC, FMEA, Pareto Charts, Process Capability, etc.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- 4 to 6 years of Manufacturing Engineering experience with process design, development and deployment.
- Bachelor’s degree in Engineering: Mechanical, Industrial, Manufacturing and Process disciplines will be considered.
Sr. Quality Engineer
Summary: Support new product development, spearhead product & process investigations & improvements and optimize supplier relationships.
- Product Development – Provide guidance on ISO & QSR requirements as part of the QA support to new product developments, lead Risk Management effo1is in accordance with ISO 14971, and lead process qualification and validation efforts, including IQ/OQ/PQ protocols and
- Product Quality -Provide leadership in the improvement of product quality through proactive means as well as complaint analysis, investigation and corrective action.
- Quality Systems – Support the ISO, EN, and MDD certification process and compliance to FDA regulations by assisting in the development, implementation, monitoring, and improvement of quality
- Supplier Quality -Responsible, along with the Supply Chain Manager and Quality Manager, for maintaining supplier relationships and providing supplier qualifications and audits. Work with suppliers to respond to any SCAR’s and to facilitate corrective actions to Non
- Production QA -Assist in the development, and improvement of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration I preventative maintenance, non-conforming materials, product lot release testing, and finished goods
- Auditing -Participates in internal audits for quality systems, processes, and products to ensure compliance with regulations and internal specificati
- Corrective and Preventative Action – Participates in development, execution, and follow up of corrective and preventative action pl
- Metrics Analysis And Reporting – Tracks and reports on quality and business measurements such as complaints, in-process defects, field failures, and non-conforming
- Knowledge of controlled environment room qualification & maintenance a plus.
- Design of Experiments background a
- Ability to use statistical techniques in the decision making
- Hire, train, and coach personnel in the department
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Engineering degree or equivalent, 5 years of experience or more.
Interested candidates should submit their resume to firstname.lastname@example.org. Please list the region and position you are applying for in the subject line of the email.