Marketing Product Manager
Are you a self-starter that is motivated by working in a fast paced, rapid growth, team focused environment? Blockade Medical, A Balt Company, is looking for highly skilled and energetic individuals to join our team!! Blockade Medical is the US arm of the original Neurovascular company. With our exciting and expanding product portfolio, we need team players that will help launch significant and innovative products to the market place. The Product Manager position offers an opportunity to manage multiple products in the ischemic or hemorrhagic stroke markets. Additionally, the rapidly changing landscape of our company will offer significant opportunity for professional growth and flexibility to allow your career to grow with us. While previous Neurovascular experience is preferred, we are looking for talented and team oriented applicants to join our team.
- 4-Year Degree in either the Life Sciences, Engineering or Business
- 5+ Years experience in medical device market
- Neurovascular experience preferred, but not required
- Previous Marketing or Sales experience preferred, but not required
- Proficient in standard MS applications (Word, Excel, Powerpoint, etc.)
- Willing and able to travel 30-50%
Senior Quality Engineer
We currently have availability for a Principal/Senior Quality Engineer to join our growing team. Blockade Medical, a Balt Company, is currently seeking an experienced Principal/Senior Quality Engineer with a minimum 5-7 year’s medical device experience in a quality control environment which includes performing quality inspections, assisting in developing new inspection and test methods, and working with the Operations and R&D teams on quality issues and initiating document changes. The position will also be an integral part of the project team for launching new products.
- Understanding inspection techniques and documentation including mechanical drawings
- Working in controlled environments (clean rooms)
- Knowledge of Quality Systems for medical device manufacturing including requirements for inspection and testing
- Plan, document (protocol and reporting) product/process validations
- Performing audits of the Quality Systems, both internal and vendors. Internal audit responsibilities includes the full-cycle internal audit planning, conducting, as well as developing, completing and reporting of corrective action plans. Vendor audits include participation in supplier qualification activities and audits.
- Initiates and/or verifies corrective and preventative actions resulting from NCMR’s, audit findings and customer complaints
- Develop and complete qualifications for new or changed materials and process
- Identify/evaluate quality inspection/test equipment requirements
- Lead Quality Circles for process improvement/problem solving
Region Sales Manager, Multiple locations: North East, Mid Atlantic, Central, Northern California
Are you an A++ sales professional that is motivated by working in a fast paced, rapid growth, team focused environment? Blockade Medical, A Balt Company, is looking for highly skilled and energetic individuals to join our team!! Blockade Medical is the US arm of the original Neurovascular company. With our exciting and expanding product portfolio, we need top tier sales professionals that are looking to be disruptive in the market and help us build a true player in the space. Over the coming months and years, we will be launching multiple products for both the hemorrhagic and ischemic stroke. Additionally, the rapidly changing landscape of our company will offer significant opportunity for professional growth and flexibility to allow your career to grow with us. While previous Neurovascular experience is preferred, we are looking for top tier, talented and team oriented applicants to join our team.
- 4-Year Degree
- 5+ Years experience in medical device sales
- Neurovascular experience preferred, but not required
- Proficient in standard MS applications (Word, Excel, Powerpoint, etc)
- Willing and able to travel 30-50%
Blockade Medical, a Balt Company, is growing and we are looking to expand our R&D Engineering team with an experienced, Level II, III or Senior R&D Engineer. A BS degree in Mechanical Engineering, Biomedical Engineering or related discipline is required with a minimum two (2) years’ experience specifically with an endovascular or medical device related background. This role will be supporting the development and manufacture of medical devices by working with the Manufacturing and Quality departments to design, develop, validate and qualify new products.
Responsibilities will include
- Development of new product concepts and products
- Completing projects following design control procedures
- Developing test methods and test fixtures
- Design, develop, refine and improve current products
- Identify processes and improvements and materials to be used in products
- Prepare product documentation
- Write and supervise test protocols, test data and test reports
- Gather input from clinical, marketing, literature, and other internal sources
- Identify problems and recommend solutions
- Assist Project Manager in scheduling and coordinating project related activities, including team meetings and design reviews
- Execute material procurement, shipping requests and documentation
Blockade Medical, a Balt Company, has a great opportunity for an experienced HR Generalist who would like to join the team of a growing, dynamic medical device company. We are seeking a team member who will play an integral role in assisting us in our anticipated growth by working directly with our VP Corporate Administration/HR in all things HR including, recruiting, onboarding, benefits administration, training and compliance, coordinating employee events, and so much more.
- Two (2) years’ experience, HR certification preferred
- Good understanding of corporate and HR procedures and processes
- Managing and coordinating recruiting efforts, job descriptions and job postings
- Processing/conducting new hire documentation, orientation and onboarding
- Open enrollment and benefits administration
- Managing performance review calendar
- Assisting with training compliance and training records maintenance
- Coordinating employee events
- Professional and articulate communicator, comfortable speaking in group settings
- Working to provide guidance and coaching with managers on disciplinary actions
- Conducting employee disciplinary or counseling meetings
- Appropriate tracking and maintenance of all records, including time sheets / time off requests, disciplinary actions, etc.
- Processing employee Leave of Absences
- Processing employee verifications
- Processing/conducting terminating employees’ documentation, exit interviews
Receptionist / Office Assistance
We are seeking a Receptionist / Office Assistant who is professional, team oriented, positive and courteous who will be an ambassador of Blockade Medical, a Balt Company. This role will vary greatly in projects and assignments from day to day, and will require an experienced receptionist / assistant who has accurate typing skills, is able to effectively articulate and communicate with customers, managers, employees and visitors, and who is able to handle multiple tasks efficiently.
- Reception support answering and directing all incoming calls
- Greeting and assisting visitors
- Supporting meetings and VIP visits and setups
- Documentation processing assistance to include copying / scanning
- Assisting with reservations, as needed
- Compiling Expense Reports, as needed
- Assisting or drafting correspondence / documents, as requested
- Filing and file maintenance for various department, as needed
- General office support
Director of Clinical Research
Blockade Medical, a Balt Company, is currently seeking a Director of Clinical Research to join our team. We are dedicated to the development of catheter based therapeutic devices and committed to bringing products to the neuro interventional field that go beyond the current standard with products that are innovative, next generation solutions to complex interventional neurovascular procedures. We have an immediate opening for an accomplished Director of Clinical Research with in-depth knowledge of clinical research operations, study design and strategies and who is able to provide direction and guidance, in accordance with Good Clinical Practices, in the initiation and development of clinical programs. The position requires the management of clinical research teams, CROs and labs, and all phases of the operational plans and execution of the clinical trials and the data collection activities for new and existing medical devices and procedures.
Minimum Qualifications / Job Responsibilities
- Comprehensive clinical trial development and execution experience in an Interventional-suite Lab/Neurovascular environment
- Extensive experience managing clinical research teams, CROs, central laboratories and other clinical study vendors
- In-depth knowledge of clinical research operations, study designs and strategies
- Demonstrated knowledge of clinical medical device standards as well as regulatory and legal aspects of clinical development
- Create immediate- to long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions deadlines
- Forecast future departmental or group needs including human and material resources and capital expenditures
- Provide technical direction and management in CRO and vendor selection
- Work with R&D to determine pre-clinical and clinical feasibility of new products.
- Work with Marketing to choose investigators and clinical sites, prepare investigators meetings and training
- Oversee proper collection of data and the development and maintenance of computerized data collection system. Manage ongoing analysis and synthesis of collected data. Analyze data and prepare documentation for submission to obtain clearance/approval for legal market distribution of medical devices
- Manage the preparation of technical and scientific publications
- Attend relevant scientific and medical meetings
Senior International Regulatory Affairs Specialist
Blockade Medical, a Balt Company, currently has a position available for a Senior International Quality Affairs Specialist to join our growing team. As a key-contributor to obtaining various worldwide approvals to commercially distribute medical products, we are seeking an experienced Regulatory Affairs Specialist with a minimum 5 year’s medical device experience, who is proficient in determining applicable registration requirements and producing submission documentation, product registrations, etc.
- Proficiency in preparing required documentation and testing for global regulatory submissions and registrations
- Determine applicable registration requirements for medical devices in all countries in which products are registered
- Interpret and/or evaluate proposed registration requirements and advise of impact of such regulations on the Company
- Review and approve labeling and promotional materials to ensure compliance with international requirements
- Work directly with consultants to manage all submissions for a particular country or countries
- Handle customs import/export requests, customer service needs, and other requests from internal customers
- Support the International Regulatory Department with regards to regulatory strategies, submissions and discussions/negotiations with regulatory authorities
- Manage communications and submission processes of global registrations including general correspondence, reports and amendments
- Proficiency in maintaining global regulatory requirements
The Senior R&D Engineer role will support the design and development medical devices. Catheter manufacturing or design experience required. The candidate will gather input from Clinical, Marketing and literature to develop new products and improve existing product lines. The candidate will be responsible for managing projects following design control procedure, develop test methods, test fixtures and manufacturing processes. The candidate will prepare design history file documentation, generate test protocol and reports. The candidate will assist the project manager in the scheduling and coordination of project related activities including team meetings and design reviews.
- BS degree in Mechanical Engineering, Biomedical Engineering or related discipline.
- Must have a minimum of two (2) years of experience in the medical device field with preference to endovascular devices.
- Experience with industry related software MiniTab, Statgraphic and Solidworks.
- Strong planning and organizational skills. Able to effectively multitask.
- Strong written and verbal communication skills.