|
Senior Quality Engineer
Job Summary
Develops, establishes and maintains quality engineering methodologies, systems, and practices. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development. Maintains risk management documentation and provides quality engineering support for the life cycle of all products.
Education/Experience
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline.
Job Duties
- Provide QA leadership to project and system for the fill lifecycle of the product, service or system
- Develop, update and maintain SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system
- Ensure Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, ect.
- Lead and support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.
Other Information
Strong and solid experience in Risk Management for medical devices
Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (including verification)
Experience with Health Hazard Analysis
Familiarity with ISO 14971
Internal Auditor/Corporate Compliance and Quality System
Job Summary
Develop yearly internal audit schedule, schedule opening and closing audit meetings, perform or assign audits, and manage the closure of internal audits by working with principal investigators, monitoring CAPA and Audit report completions. Technical representative for external regulatory audits. Ensure successful responses and improvements for any external audit findings.
Education/Experience
- BS Engineering discipline, Health Care or related degree.
- Minimum of five years of progressive compliance audit experience with significant exposure to Quality System/ Health Care regulations (medical device) compliance concepts. Knowledge of information technology systems, databases, spreadsheets and word processing required.
- Minimum two years experience in Medical Device manufacturing environment, or equivalent experience working in a regulated industry
- Comprehensive understanding of QSR (21CFR820), ISO 13485, MDD and CMDAS requirements for medical device manufacturing.
- ASQ CQA, RAPS or ISO Lead Auditor certification required. May consider equivalent formal lead auditor certification for Quality System auditing.
Job Duties
- Develops Internal Audit plans for ensuring compliance with company policies and procedures and for regulatory compliance to local requirements in all countries where products are sold.
- Responsible for the coordination and oversight of quality, clinical, compliance and international business practice audits. Directs and performs regulatory compliance program audits, consisting of reviews based on the company’s internal issues identification system, the OIG annual work plan, reviews identified during internal risk assessments, and reviews requested by the Compliance Department or other appropriate areas to assure compliance with US and International Health Care requirements.
Senior Product Manager
Job Summary
Manages the activities of product marketing and supports the Director of Marketing in the development of strategic business plans. Implements and executes marketing plans and programs. Implements and executes the planning, development and production (execution) of promotional programs and materials. Responsible for global marketing plans for product/product group.
Education/Experience
- Four-year undergraduate degree, preferably in business, marketing or related field.
- 5-10 years experience as a product manager or similar marketing or business position.
Job Duties
- Manages the development, implementations and execution of marketing plans by the concerned product managers. Marketing plans incorporate strategic objectives, action plans, forecasts and budgeting. Develops strategic plans for their assigned product lines. Consolidates the product line marketing plans into an overall Marketing plan. Submits the Marketing plan to the Director of Marketing for approval.
- Supports the Director of Marketing in the development of strategic business plans. Ensures that the strategic objectives of the corporation are communicated to the appropriate positions.
- Identifies, develops analysis and recommends on product market developments to the Director of Marketing directly.
- Ensures the collection and analysis of market data. Supports in the development of market research programs. Utilizes market data in directing the development of specific marketing plans.
- Directs new product developments and introductions to the market. Intercedes with other functional groups as needed to solve problems.
- Ensures the planning, development and production of marketing communication. Both product and customer related. Ensures that programs and materials are in line with corporate and strategic marketing objectives.
- Ensures the participation of sales organizations on the development of marketing and communication programs. Coordinates with sales functions to assure understanding and support of marketing programs.
- Consolidates and manages the marketing expense budget. Ensures that expenditures support the marketing objectives.
- Participates in the development of seminars. Assists in defining content.
- Assures effective functional replacement in case of absence.
Senior Technician
Job Summary
This position will support for development of medical laser catheters. The senior technician will assist in managing the R&D laboratory and perform in vitro testing per approved procedures, writing final reports of testing, building devices and associated troubleshooting.
Education/Experience
- Associate degree in Engineering or equivalent.
- Typical experience required is 5+ years as a technical associate in the medical device field.
- Working knowledge of LabVIEW or other data acquisition.
- Experience with SolidWorks CAD system is highly desirable.
- Knowledge and understanding of Agile system required.
Job Duties
- Apply and formulate unique engineering techniques to general problems associated with catheter design, building, and manufacturing.
- Analyze data and arrive at troubleshooting conclusions.
- Recognize errors or discrepancies in data via statistical methods and propose explanations for the discrepancies and implement solutions.
- Technical problem solving ability responsible for day-to-day operation of R&D laboratory.
- Supervise R&D laboratory including all test equipment and their maintenance and calibration that supports the teams’ work.
- Solicits and assesses vendor capabilities for proposed technology development tests.
- Maintains accurate lab notes.
- Perform testing to verify design requirements are achieved.
- Develops cost, and scheduling plans for R&D laboratory project.
Technician I
Job Summary
Improve the efficiency and quality of the Product Development group by performing routine lab functions thereby freeing engineering resources to perform higher level tasks.
Education/Experience
- High school degree or GED, prefer some college experience preferably in a technical field
- Minimum of 6 months experience in the medical device field, prefer experience in manufacturing or other technical area
- Experience following written procedures and documenting work performed
- Prefer experience in lab environment
- Prefer experience with machine shop tools and use
Job Duties
- Maintain lab environment (cleanliness, organization, etc.)
- Maintain lab equipment including calibration, preventative maintenance, and interaction with vendors
- Use of all lab equipment, setup and tear down
- Maintain inventory of lab supplies and equipment
- Setup test systems, conduct testing and document results
- Maintain laboratory notebook
- Support project teams with prototype builds
- Research and specify equipment (new equipment needed to improve lab)
- Create lesions, and other test materials
- Perform basic machining to create test fixtures, etc.
Regulatory Affairs Manager (International Submissions)
Job Summary
This position will focus primarily on the preparation, publication, quality control, and delivery of paper and electronic components of all submissions to introduce new products to international markets. Incumbent will prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Education/Experience
- BA/BS or equivalent relevant work experience
- 3-5 years experience in a regulatory submission experience
- Thorough understanding of regulatory requirements and relevant government regulations
Job Duties
- Function as key regulatory affairs point person for all international submissions and CE applications
- Prepare document packages for regulatory submission, including Shonins, FDA 510(k), IDE, PMA(S), STED, Design Dossiers, and Device License Applications
- Work with Clinical Affairs, Marketing and Product Development to ensure that regulatory requirements for assigned projects are met
- Serve as a Regulatory representative to Project Teams as needed for assigned projects or products.
- Assistance in the development of submissions through the review process
- Tracking and facilitating the progress of submissions through the review process
- Review of protocols and reports to support regulatory compliance and submissions
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations
- Interact with various regulatory agencies to accomplish product clearances
- Participate on development teams and communicate regulatory requirements for product development
- Review and approve test protocols and reports to support regulatory submissions
- Review device labeling and advertising materials for compliance with submissions and applicable regulations; recommend changes when appropriate
- Organize and maintain RA documentation and collaterals
- Assist in developing systems to improve regulatory efficiency and improve quality
- Keep updated on regulatory authorities’ requirements on technical/format aspect of submissions and ensure incorporation into Spectranetics standards
Other Information
Proficient in establishing priorities and setting/executing project plans
Ability to handle multiple projects and competing timelines
Excellent interpersonal, verbal and written communication
Regulatory Affairs Manager (US Submissions)
Job Summary
This position will focus primarily on the preparation, publication, quality control, and delivery of paper and electronic components of all submissions to introduce new products to the United States. Incumbent will prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Education/Experience
- BA/BS or equivalent relevant work experience
- 3-5 years experience in a regulatory submission experience
- Thorough understanding of regulatory requirements and relevant government regulations
Job Duties
- Function as key regulatory affairs point person for all US new product submissions
- Prepare document packages for regulatory submission, including FDA 510(k), IDE, PMA(S), STED, Design Dossiers, and Device License Applications
- Work with Clinical Affairs, Marketing and Product Development to ensure that regulatory requirements for assigned projects are met
- Serve as a Regulatory representative to Project Teams as needed for assigned projects or products.
- Assistance in the development of submissions through the review process
- Tracking and facilitating the progress of submissions through the review process
- Review of protocols and reports to support regulatory compliance and submissions
- Review device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
- Interact with various regulatory agencies to accomplish product clearances
- Participate on development teams and communicate regulatory requirements for product development
- Review and approve test protocols and reports to support regulatory submissions
- Review device labeling and advertising materials for compliance with submissions and applicable regulations; recommend changes when appropriate
- Organize and maintain RA documentation and collaterals
- Assist in developing systems to improve regulatory efficiency and improve quality
- Keep updated on regulatory authorities’ requirements on technical/format aspect of submissions and ensure incorporation into Spectranetics standards
Other Information
Proficient in establishing priorities and setting/executing project plans
Ability to handle multiple projects and competing timelines
Excellent interpersonal, verbal and written communication
Engineer II
Job Summary
Supports the design and development of product.
Education/Experience
- BS in Engineering
- Experience required is 3 years as an Engineer I
Job Duties
- Conducts research programs for the development of new and existing product. This includes researching materials, techniques, competitive product, etc., presenting the information to the team, and making recommendations.
- Occasional one-on-one exposure to customers. May be a part of a larger group or have a specific agenda.
- Designs test methods to evaluate design (component through final device). This may include modifications to existing test methods.
- Develop accurate and complete test protocols for component, sub-assembly, and final assembly testing.
- Designs new products given specific requirements and constraints. This may include component, sub-assembly, and final device level design. Complex or novel designs may require assistance from more experienced engineers.
- Produce working models of new product designs, which may include assembly and machining.
- Generates accurate and complete component specifications and assembly procedures.
- Proficiency in CAD is expected. Complex modeling may require assistance.
- Solicits and assesses vendor capabilities for proposed component fabrication. Makes vendor recommendations based on the information gathered.
- Maintains accurate lab notes.
- Generates invention disclosures for new design concepts within the scope of the project.
- Design in-process controls and testing to verify design requirements are achieved.
- Maintain the device history file for new products.
- Conducts design and peer reviews for new products.
- Assists in developing cost, resource, and scheduling plans for a new project.
- Assist the team in presenting information to senior management at project phase review.
- Performs and is responsible for most duties involved in an assignment.
- Apply and adapts standard engineering techniques to general problems.
- Captures formats and analyze data.
- Recognizes errors or discrepancies in data and proposes explanations for the discrepancies.
Human Resources Generalist
Job Summary
The Human Resources Generalist is responsible for functions that contribute to the development and delivery of strategic and day-to-day Human Resources functions.
Education/Experience
- Bachelor’s degree or equivalent work experience within Human Resources preferred
Job Duties
- Actively participates in the recruiting efforts of SPNC to include job posting, resume screening, applicant flow log maintenance and coordination of structured interview process
- Actively participate in the Company’s hiring process to include offer letter generation, background checks, relocation programs and new hire paperwork coordination
- Provide support to employees and managers regarding benefit, payroll and policy issues and/or inquiries
- Assists with annual open enrollment process; Arranges for distribution of materials from carriers; assists with communicating changes to employees
- Develop, prepare and generate internal reports using HRIS system
- Assists in the preparation of employee separation notices and related documentation
- Assist in the preparation of various employee communications including the Company’s quarterly newsletter
- Responsible for creating and administering the Company’s employee recognition programs
- Deliver on assigned HR strategic initiatives
Other Information
3-5 years of Human Resources Generalist experience
Excellent interpersonal, oral and written communication skills
Ability to manage multiple projects, set priorities, exercise sound judgment and clearly communicate findings and advice
Experience in handling sensitive, confidential information
Facilities Technician
Job Summary
Operates and maintains mechanical, electrical, instrumentation and controls, and life safety systems. Ensures high quality delivery of facilities systems and compliance with specified limits and reliability expectations. Owns resolution of customer issues.
Education/Experience
- Techincal degree preferred
Job Duties
- Responsible for daily operations and maintenance of facilities equipment and systems. Performs rounds, identifies and resolves system issues. Monitors/trends performance of facilities parameters to proactively minimize excursions.
- Ensures optimal operations of systems to minimize energy consumption. Performs system troubleshooting and development of corrective action plans. Responsible for preventative and corrective maintenance.
- Coordinates maintenance activities with COPT, manufacturing and other stakeholders.
- Interfaces with COPT to ensure quality of operations and services for leased systems.
- Additional responsibilities include but not limited to: administration of various compliance programs, support for project execution, interface with vendors for performance and cost savings.
- Monitors facilities for compliance with health and safety standards.
- Ensures compliance with quality standards.
Other Information
A minimum of two years of experience in facilities operations/maintenance is required with specialized skills in HVAC and electrical systems.
Knowledge of safety codes and regulations is required.
Marketing Intern
Job Summary
Incumbent will be involved in a variety of projects supporting the goals and objectives of the Lead Management Marketing department.
Education/Experience
- Enrolled in a Bachelor program at a four year credited university
- Major in Marketing is preferred
Job Duties
- With close supervision, uses established procedures and policies to perform prescribed tasks related to Lead Management Marketing
Other Information
Must possess strong written and oral communication skills
Field Service Engineer
Job Summary
To install, service, repair and support highly technical electronic and laser equipment at customer sites worldwide ensuring the operational quality of all company products and complete customer satisfaction. This position provides technical phone support to co-workers on the operation of all company equipment.
Education/Experience
- A bachelor’s degree in electronics or technical field or an AS in laser/electronics technology or equivalent experience
Job Duties
- Evaluates, diagnoses and repairs a wide variety of system and equipment malfunctions and provides preventive maintenance on equipment for customers
- Serves as liaison between customer and Management on standard service related and technical matters
- Provides on-site direction to customers on the operation and maintenance aspects of assigned equipment
Other Information
Job will be located in the Indianapolis area
|
Benefits
Current Openings
Back to the Top