We are looking for someone with a minimum of five years hands-on experience maintaining and managing all IT and communications infrastructure including administration of corporate servers & services as well as support of individual workstations, phones and wireless devices. A bachelor’s degree or equivalent experience is required as is a MCSA/MCSE or willing to certify within 6 months of hiring. Key knowledge and abilities required include:

• Recent hands-on experience supporting MS Windows Server (2003 & 2008) and workstation (XP Pro & “7 Pro”), local area networks and file & print services.
• Knowledge and hands-on experience with Active Directory and Group Policies, security, LAN & WAN communications, MS Exchange (2003/2010), ActiveSync and MS Office.
• Advanced administration, performance tuning, troubleshooting, and recovery experience with current MS Exchange environments including email filtering and archiving.
• Knowledge of and experience in supporting cell phones, iPhone, iPad & BlackBerry devices, and wireless broadband internet devices. Knowledge of Exchange ActiveSync required, BlackBerry Enterprise Server experience a plus.
• Knowledge of and experience in Great Plains 10 or later versions, and its MSSQL Backend a plus.

You should have a true customer focus, an ability and desire to multi-task, and a willingness to take ownership through completion of all responsibilities. Must be a self-starter, have strong interpersonal skills, and be flexible in a dynamic team environment. Foreign language skills, especially German, add to your value. Some travel (up to 10%) will be required.

The ideal candidate should be no stranger to maintaining security of company file systems and data using approved hardware, software tools and processes, including VPN channels, firewalls and filters, and active anti-virus/spyware/spam tools.

Interested candidates please email your resume, cover letter, and salary requirements to our Human Resources Department via email: Submit Resume

Heidelberg Engineering offers a comprehensive benefits package including:

• Medical, Dental, and Vision Insurance Programs
• Life and AD&D Insurance
• Short Term and Long Term Disability
• Flexible Spending Accounts
• Employee Assistance Program
• Additional Voluntary Benefits
• Paid personal time off and holidays
• 401(k) Savings Plan

Heidelberg Engineering is headquartered in Heidelberg, Germany with US offices located in the Carlsbad Research Center in Carlsbad, CA. The company is a pioneer in innovating precision instruments to help detect and manage treatment of eye diseases that can lead to blindness. This is a great opportunity to help others while enjoying a challenging position in a small but growing enterprise.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Launch new products, next generation products, and product enhancements so that the product is continuously changing to meet market needs.
• Create and implement the annual marketing plan.
• Create and implement the long-term product strategy, including product enhancements and new product development.
• Responsible for thought leader development and partnership with key opinion leaders (KOL’s) as appropriate for the development of strategy and programs. Provide resources to advisors and speakers.
• Identify, quantify and develop plans for market based opportunities.
• Continuously monitor market needs and customer acceptance through sales force contact, customer visits, attending key congresses and meetings, and conducting primary and secondary market research.
• Monitor sales and profits and report on product line performance to management, utilize sales analysis skills to understand and report on product and market dynamics.
• Analyze competitive products and incorporate competitive strategies into promotional and product development plans to stay ahead of the competition.
• Analyze technical data, data security, and networking to increase product enhancement.
• Provide technical support and sales tools to field and product support personnel.
• Develop and implement the promotional plans and materials including: exhibits, advertising, product literature, speakers, AV and multi-media materials, web marketing, etc.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

• Bachelor’s degree in marketing, communications, business, engineering, or related field; or equivalent combination of training and experience. MBA is preferred
• Minimum of 3 years experience in the product development process, preferably at a medical device company. Demonstrated product launch experience.
• Excellent verbal and written communication skills.
• Good analytical skills and ability to manage and work cross-functionally.
• Strong business acumen and abilities relating to commonly used marketing and project coordination concepts, practices and procedures.
• Strong project management skills; must be customer-focused, deadline-oriented, meet estimated costs/budgets, and manage multiple tasks.
• Ability to work independently and as part of a team
• Work in an FDA regulated environment, knowledge and experience with FDA required review process.
• Excellent computer skills in the following programs:  MS Word, PowerPoint, Excel and MS Project; Office 2007 preferred.

Heidelberg Engineering, Inc.
1808 Aston Ave., Suite 130
Carlsbad, CA 92008
800-931-2230

Submit Resume

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Prepares, reviews and submits necessary regulatory information to FDA to obtain 510(k) clearance and PMA approval of products.
• Coordinates with various functional areas in the preparation, review and submission of IDE applications for clinical studies, as well as other clinical studies including marketing studies.
• Reviews all submissions to FDA and international agencies for completeness, truthfulness and compliance with regulations.
• Serves as the primary contact to FDA for review of submissions to FDA.
• Keeps up-to-date on proposed regulations and guidelines published by FDA and international agencies.
• Reviews advertising and promotional material and device labeling for regulatory compliance.
• Controls the introduction of product through the United States market through management of the release approval process.
• Initiates changes to practices and procedures to support compliance requirements
• Brings regulatory and corporate compliance questions/issues to the attention of senior management
• Provides general guidance or training support of professional staff.
• Provides interpretations & direction to applicable company personnel regarding the regulatory aspects associated with relevant functions.
• Acts as Corporate Compliance Officer to review, audit and ensure compliance with corporate compliance policies and procedures.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Minimum of BS/BA in scientific or engineering discipline or equivalent combination of education and experience. MS or JD preferred.
• 10-15 years of successful experience in related field and successful demonstration of increasing responsibility and accomplishment in the responsibilities described above.
• Experience in the medical device industry preferred, but relevant experience in the area of combination products (drug/devices) will be considered.
• Demonstrated excellent writing skills in the preparation of technical documents based on technical reports prepared by other technical functions.
• A thorough understanding of U.S. FDA regulatory laws and requirements to ensure compliance to regulations without hindering business and growth and understanding of regulatory laws in major international markets.
• High levels of professionalism, ethics and compliance in order to interact with FDA and serve as a representative of Heidelberg Engineering.
• Strong written and oral communication skills in order to facilitate communications with FDA and minimize unnecessary FDA inquiries.
• Advanced degree may be substituted for experience, where applicable.
• Approximately 20% of time may require domestic and/or international travel.
• German language ability strongly preferred.

Heidelberg Engineering, Inc.
1808 Aston Ave., Suite 130
Carlsbad, CA 92008
800-931-2230

Submit Resume