Solta Medical Inc. (SLTM) is a global leader in the medical aesthetics market providing innovative safe and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address a range of skin issues under the industrys six premier brands: Thermage® Fraxel® Isolaz® CLARO® Clear + Brilliant™ and Liposonix®. Thermage is an innovative non-invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Isolaz was the first light based system indicated for the treatment of inflammatory acne comedonal acne pustular acne and mild-to-moderate inflammatory acne. CLARO is a personal care acne system that is the first FDA cleared over-the-counter IPL device that uses a powerful combination of both heat and light to clear skin quickly and naturally. Clear + Brilliant is a unique cost-effective treatment that utilizes safe fractional laser technology to prevent and maintain early signs of aging. Liposonix is a non-surgical treatment to reduce waist circumference with advanced high-intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat beneath the skin. Since 2002 approximately one million Thermage Fraxel and Isolaz procedures have been performed in over 100 countries.
Our mission is to be the leader in developing transformational aesthetic products procedures and services; building world class brands; and providing long term value for our stakeholders.
Solta Medical is looking for dedicated individuals who thrive in a creative challenging and professional environment - where respect for the energy of new ideas diversity and teamwork can be found at every level of the organization. We create new opportunities for physicians and the patients they serve. And of course opportunities for our employees to grow and thrive.
Position Title: Packaging Engineer
Description: S/he defines package requirements based on product cost regulatory environmental and/or customer needs. S/he is responsible for coordinating the cross-functional activities of engineering marketing quality/regulatory production/logistics and contract packaging/labeling suppliers. May develop new packaging or containers to meet established requirements and maintains oversight and quality of existing packages/containers necessary to support the shipment of Solta’s products across all brands. Responsibilities include documentation management and an understanding of good manufacturing practices (GMPs). Uses appropriate tools and performs integrity analysis of packaging. The ideal candidate is a self-starter that exhibits good judgment and can pursue projects with little instruction from day-to-day.
Reports To: Director of Sustaining and NPI Engineering
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• Plans and performs packaging development tasks to support new product development or legacy product improvement.
• Supports resolution of packaging related issues including documentation test component evaluation Process Validations customer failures performance issues and processing engineering change orders.
• Assists in achieving cost -reduction objectives.
• Resolves packaging problems and performs testing to evaluate and analyze packaging alternatives.
• Prepares and approves design changes (ECOs).
• Coordinates packaging efforts with Logistics Marketing R&D engineering Quality Planning and Purchasing.
• Generates packaging procedures work instructions travelers and/or tracking documents to control and define packaging processes to validate packaging designs to meet QSR and ISO requirements.
• Collects and reports on product failure/root cause data collected during packaging shipping and installation activities to support current product improvement and future product development.
Experience Education Training Traits:
• BS in Packaging Mechanical or Manufacturing Engineering is preferred but equivalent work experience is acceptable.
• Minimum 5 years packaging engineering or supplier management experience preferred.
• Familiar with packaging materials and packaging supplier management.
• 2 years experience in a medical devices environment.
• Working knowledge of cGMP and cGDP.
• Strong knowledge of FDA and ISO Quality System Regulations
• Excellent written and oral communication skills
• Excellent team-work skills and ability to work well with a multicultural workforce.
• Proficient in MS Office (Word Excel Power-point)
• In addition this person must be high-energy enthusiastic creative and willing to drive projects through to completion on schedule and within budget.
Language and Verbal Skills
Ability to read analyze and interpret engineering specifications general business periodicals professional journals technical procedures or governmental regulations. Should have the ability to write clear concise reports specifications business correspondence procedures and manuals and to effectively present information.
Ability to work with probability and statistical inference fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions percentages ratios and proportions to practical situations.
Analytical and Reading Skills
Ability to define problems collect data establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.
While performing the duties of this job the employee may be required to perform lifting tasks of up to 35 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
The noise level in the work environment is usually moderate. Some work maybe required to be performed in animal and clinical laboratories where the employee must employ standard techniques to protect against chemical and biological hazards. Some machining and prototyping activities will involve moderate noise levels (i.e. power drill milling machine) and moderate dust or debris exposure.
Solta is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe cooperative and productive work environment thus ensuring the health and safety of themselves and others.
Thermage, Inc. is engaged in designing, developing, manufacturing and marketing medical devices for the non-invasive treatment of wrinkles....