Rhytec, Inc. is an innovative and rapidly growing medical device company specializing in the field of Dermatology and Plastic Surgery. Our corporate objective is to develop innovative technologies based on sound scientific and clinical research to fulfill unmet needs of these specialized markets. To support this objective, we believe in fostering innovative thinking and nurturing entrepreneurial talent. In doing so Rhytec is able to find and retain outstanding employees.

Rhytec is always looking for individuals with distinctive backgrounds and broad perspectives to join our team. We attract people who engage in pioneering thought processes and are seeking a collaborative, flexible business environment and who enjoy working in a team atmosphere.

We offer a competitive compensation package for highly motivated individuals. For positions available in the United States, email your resume to Rhytec at hr@rhytec.com

U. S. Citizenship or a valid work permit is required for all positions. Rhytec, Inc. is an Equal Opportunity Employer.

Rhytec, Inc. does not accept unsolicited resumes from contingency firms. If you are interested in receiving consideration to work on positions in the future, please forward your contact information to hr@rhytec.com. Please reference the full job title in the subject line of your e-mail.


Available Positions


Clinical Research /Data Associate

Responsibilities:

The Clinical Research/Data Associate is responsible for assisting the Clinical Research Manager in developing the data management processes and meeting corporate goals. The ideal candidate will possess experience in both Clinical Research and Data Management positions. Position growth will be based on performance. Clinical Research/Data Associate will work with project team to ensure successful completion of trials in accordance with current federal regulations and SOPs. The successful candidate must be capable of wearing many hats and therefore must be flexible and task oriented. Self-starter who can work relatively independently is strongly desired.

The selected candidate will be responsible for:

Data Responsibilities:

The Clinical Research/Data Associate is responsible for providing accurate and documented clinical databases that will be used for analysis of study results and possible presentation to regulatory agencies. You will be relied on to ensure the clinical database accurately reflects the data collected from the clinical sites. Primary responsibilities include:

  • Assisting with the creation of Data Management SOPs
  • Implements Quality Control procedures for Data Management.
  • Initiates corrective action as appropriate and resolves data discrepancies with appropriate personnel in Clinical
  • Preparation of case report forms based on clinical protocols
  • Creation and management of databases according to SOPs and Federal Regulations
  • Receipt and tracking of case report forms
  • Case report form review and query creation and tracking
  • Data Entry and File maintenance
  • Preparing data for final study report
  • Preparing data for submission to various regulatory authorities
  • Receiving photos and maintaining photo database for each study

Clinical Responsibilities:

  • Liaise with current customers who are interested in Investigator Initiated Trials
  • Assist IITs with protocol and case report form development
  • Act as primary contact for Investigators throughout IIT process
  • Maintain communications on a regular basis with the investigator and/or his/her assigned contact
  • Communicate findings from contact reports and monitoring visits to appropriate staff in a timely manner
  • Assure adequate reporting of adverse events, protocol deviations, and patient status
  • Maintenance of trial master file/site files and related database, as well as photo database

Skills, Education and Experience:

  • Bachelors degree in health related discipline
  • Good interpersonal and communication skills (verbal and written)
  • Self motivation, attention to detail and organizational skill are key to success
  • Must have excellent working knowledge of MS Word, Excel and Access
  • At least one year experience in working with Investigator Initiated Trials
  • Knowledge of the principles of good clinical data management
  • Strong analytical and organizational skills and willing to work in a fast paced environment
  • Strong knowledge of FDA Regulations, 510K and IDE studies and Good Clinical Practices
  • Excellent communication skills and able to interface with multifunctional team members and present information in concise and effective manner

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Manager/Director, Regulatory Affairs

Responsibilities:

The Manager/Director of Regulatory Affairs is responsible for developing and executing the global Regulatory strategies and activities of the company.

The selected candidate will be responsible for:

  • Support multidisciplinary project teams by providing Regulatory input and strategy
  • Manage regulatory aspects of complaint handling activities as a member of the Incident Review Board
  • Determine strategy and requirements for 510k’s
  • Coordinate, prepare and manage IDE, 510(k), and PMA, submissions, supplements and annual reports as well as International registration submissions
  • Lead in all communication and negotiations with FDA relating to requirements for device approvals including clinical protocols
  • Review, advise and approve labeling, including sales and marketing materials, protocols, publications and control changes for regulatory compliance
  • Support all internal and external engineering efforts in the development and design of new products
  • Responsible for training and maintaining FDA compliance requirements are met and written procedures are followed
  • Manage the development, implementation, update and maintenance of regulatory systems and activities
  • Orchestrate and implement the internal audit program
  • Actively participate in Regulatory Affairs meetings to remain up to date on potential changes in FDA policy or surveillance activities particularly as they relate to the Company’s business

Skills, Education and Experience:

  • Bachelor of Science or equivalent with advanced degree preferred
  • Minimum of 5 years experience in Regulatory field for medical device company
  • Experience with Class II and or Class I medical device companies
  • Experienced leader with exceptional interpersonal and communication skills
  • Must be organized with attention to detail
  • Prior experience and direct interaction with FDA review panels and processes
  • Solid understanding of international regulatory standards; FDA, CE and MHW
  • Ability to multitask and work in entrepreneurial environment
  • Solid computer and written communication skills

Senior Product Design Engineer

Responsibilities:

The Senior Product Design Engineer is an active participant of the core design and development team that will design and develop prototypes, and transition them into manufacturing. Provide technical direction and oversight to internal and external co-development activities with respect to mechanical and product design and engineering. Instrumental in vendor assessment and coordination. Represent R&D in such activities as Design Reviews, Installation, Service and Clinical Research.

  • Overall design and development of enclosures/sub-assemblies for electro-surgical generators, energy delivery devices and accessories using a range of fabrication techniques in a range of materials
  • Styling, aesthetic and ergonomic design
  • Rapid prototyping of parts using third-party suppliers
  • Design of injection molded polymer parts for manufacture by third-party suppliers
  • Setting up 3-D CAD system to meet the growing needs of the company and ensuring integration with an MRP system
  • Ensuring sub-assembly and integrated designs not only meet requirements but are also compliant with IEC/UL 60601-1, -2-2 and other standards as required
  • Creating design specifications, design verification/validation, production/service related and other documentation
  • Creating design specifications, design verification/validation, production/service related and other documentation
  • Ensure product meets all applicable international and domestic standards and safety requirements

Skills, Education and Experience:

  • B.S.M.E. and M.S.M.E. or equivalent.
  • Significant experience in managing both technology and product development in the medical device industry
  • Experience bringing products from concept to production
  • 8+ years of product development experience with increasing responsibilities in scope, scale and complexity
  • Proven performance record
  • Strong organizational and communication skills, both written and oral
  • Proven technical leadership capability, including ability to identify and solve technical problems
  • Proficiency in the use of various business and engineering software
  • Proven track record of accomplishing objectives on schedule and budget while assessing and managing risk

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Sr. Electronic Design Engineer

Responsibilities:

The Senior Electronic Design Engineer is an active participant of the core design and development team that will design and develop prototypes, and transition them into manufacturing. Provide technical direction and oversight to internal and external co-development activities with respect to Electrical and Mechanical Engineering. Instrumental in vendor assessment and coordination. Represent R&D in such activities as Design Reviews, Installation, Service and Clinical Research.

  • Design and development of universal ac input power-factor corrected supplies to circa 500 W
  • Design and development of high-power/pulsed high-voltage supplies (e.g. 4 kV, 2.5 kW pulsed, average power 180 W). Design and development of other, mainly analogue circuitry ,but understanding of integration with an embedded controller an advantage
  • Setting up a pcb CAD system to meet the growing needs of the company and ensuring integration with an MRP system
  • Creation of circuit schematics, theoretical modeling and supervision of pcb layouts
  • Design FMEA
  • Ensuring sub-assembly and integrated designs not only meet requirements but are also compliant with IEC/UL 60601-1, -1-2, -2-2 and other standards as required
  • Creating design specifications, design verification/validation, production/service related and other documentation
  • Ensure product meets all applicable international and domestic standards and safety requirements

Skills, Education and Experience:

  • BSEE or Equivalent, MSEE preferred
  • Significant experience in managing both technology and product development in the medical device industry
  • 8+ years of product development experience with increasing responsibilities in scope, scale and complexity
  • Proven performance record
  • Strong organizational and communication skills, both written and oral
  • Proven technical leadership capability, including ability to identify and solve technical problems
  • Proficiency in the use of various business and engineering software

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Territory Sales Representative for the following territories:

Alabama, Tennessee
Minnesota
Philadelphia, Southern New Jersey, Maryland, Washington DC

Responsibilities:

The Sales Representative is responsible for all of the activities a Sales Representatives in the efforts to sell the Rhytec product lines. The Sales Rep will collaborate with the Regional Sales Manager in the formation of a strategic and tactical sales plan, and be responsible for customizing and implementing it to their particular region. They will be responsible for developing and championing innovative strategies and tactical initiatives in an effort to meet and exceed sales goals.

The selected candidate will be responsible for:

  • Build a collaborative working relationship with key physicians and thought leaders in the industry
  • Develop and grow customer base in region by utilizing marketing and sales tools, as well as shows and seminars
  • Act as a technical and product resource to physicians to further knowledge on patented technology and its competitive advantage in marketplace
  • Operate within established Regional budget

Skills, Education and Experience:

  • Candidate must have the ability to establish rapport and motivate customers and key thought leaders
  • Must possess a proven outstanding track record of success in previous device sales in the Dermatology and Plastic Surgery markets
  • Working knowledge of laser and light source devices strongly preferred
  • Ability to excel in entrepreneurial environment
  • Highly motivated self starter with excellent organizational ability
  • B.A. or B.S. required
  • Minimum 3 years capital equipment sales experience. Dermatology and Plastic Surgery market preferred. Superior communication skills, both oral and written
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