Sensors for Medicine and Science, Inc. - Oxygen Sensors and Glucose Sensors

Current Open Positions

Polymer Chemist

Sensors for Medicine and Science, Inc., a small but growing medical device company, has an opening for a polymer chemist. A Ph.D. in polymer chemistry and a hands-on knowledge of polymer synthesis is required. The scientist should be able to independently design and synthesize polymers with desired chemical and physical properties. Experience in the preparation of polymers for medical devices is a strong plus. Excellent communication skills and the ability to work in a dynamic cross-disciplinary environment are also required.

We offer competitive salaries and benefits. For consideration, please submit your resume electronically to admin@s4ms.com or by mail or fax to:

Sensors for Medicine and Science, Inc.
Attn: MM0408
20451 Seneca Meadows Parkway
Germantown, MD 20876
FAX: 301-515-0988

Equal Opportunity Employer

Entry Level Chemist/Biochemist

Sensors for Medicine and Science, Inc., a small but growing medical device company, has an opening for a Chemist/Biochemist to perform bench-top level analytical testing and wet chemistry as part of our R&D group. A minimum B.S. degree in chemistry or biochemistry is required. The candidate should have hands on experience with basic analytical instrumentation and wet chemistry techniques. Strong academic credentials and some undergraduate or industrial research experience are preferred. Excellent communication skills and the ability to work in a dynamic cross-disciplinary environment are also required.

We offer competitive salaries and benefits. For consideration, please submit your resume electronically to admin@s4ms.com or by mail or fax to:

Sensors for Medicine and Science, Inc.
Attn: MM0308
20451 Seneca Meadows Parkway
Germantown, MD 20876
FAX: 301-515-0988

Equal Opportunity Employer

Electrical Engineer

Job Description

An electrical engineer with demonstrated microelectronics experience in analog and digital circuit design to work on the development of scientific and medical sensor platforms. Candidate must have an aptitude and desire for hands-on laboratory work with strong team oriented skills and abilities.

Experience:

1-3 years experience with mixed signal circuits and familiar with wireless and RFID technology
Proficient using industry grade schematic, simulation, layout, and CAD software tools
Familiar with RF telemetry, optical sensors, and MCM assembly technology
Experience using Verilog, VHDL and/or microcontroller assembly is a plus

Education

MS or Ph.D. in Electrical Engineering, Physics, or equivalent

Knowledge

Job requires a self-motivated person with a strong technical background along with hands-on experience integrating, testing and troubleshooting electrical systems. Candidate must have strong communication and inter-personal skills to work effectively in a fast paced team environment. Candidate must have strong analytical and writing skills to analyze, design, test and integrate systems. As a member of an R&D engineering team, this individual will support system design, circuit/sensor analysis, and manufacturing activities.

We offer competitive salaries and benefits. For consideration, please submit your resume electronically to admin@s4ms.com or by mail or fax to:

Sensors for Medicine and Science, Inc.
Attn: Ad 0208
12321 Middlebrook Road, Suite 210
Germantown, MD 20874
FAX: 301-515-0988

Equal Opportunity Employer

Electrical Engineer

Job Description

An entry-level electrical engineer with demonstrated electronics development skills to work in the exciting field of medical device development.

Experience:

Proficient using industry grade schematic, simulation, layout, and CAD software tools
Experience designing, assembling and troubleshooting PCB’s
Familiar with optical sensor interface circuitry
Experience using microcontroller assembly and visual basic programming languages

Education

BS in Electrical Engineering or equivalent

Knowledge

We offer competitive salaries and benefits. For consideration, please submit your resume electronically to admin@s4ms.com or by mail or fax to:

Sensors for Medicine and Science, Inc.
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
Facs: (301)-515-0988

Equal Opportunity Employer

Director, Clinical and Regulatory Affairs

Interface with outside corporate partners as needed.

Clinical Strategy
Develop and implement SMSI's global clinical development strategy. Manage at least one development program, including several subprojects. Select methods, techniques and evaluation criteria for obtaining desired study results. Ensure budgets, schedule and performance requirements are met. Direct label development process. Develop protocols and other study documents. Select clinical advisors/investigators with eye toward global opinion-leader support. Interact/negotiate with clinical sites and investigators, and supervise activities of contractors. QA/QC of clinical data. Coordinate data collection, submission and analysis; prepare reports, and coordinate activities of other departments. Develop and update SOPs for Clinical Development. May be responsible for supervising activities of other personnel, training and continuing education.

Regulatory Strategy
Develop and implement SMSI's global regulatory strategy. Integrate strategy into product development plans and implementation. Analyze US regulations and guidances. Design regulatory dossiers by considering the scientific and regulatory perspective that will be most effective in obtaining a successful filing. Anticipate potential registration issues and develop strategies to address and quickly resolve problems. Prepare, implement, communicate, and coordinate regulatory projects, plans and schedules with scientific, manufacturing, business and external project team members. Responsibilities will include: monitor related corporate activities for regulatory compliance, including all preclinical and clinical plans and practices, product distribution, and marketing-related plans and practices. Prepare, assemble, review and submit regulatory information to FDA and other regulatory agencies including, but not limited to, IDEs, PMAs, responses to FDA, manufacturing, preclinical and clinical protocols and amendments, and adverse experience reports.

FDA Interactions
Lead interactions and negotiations with regulatory authorities, including FDA. Represent the company's commercial and scientific interests to regulatory authorities. Manage the preparation for FDA meetings and provide strategic guidance on the organization of these meetings. Work with regulatory authorities to develop solutions consistent with SMSI strategy and registration requirements. Ensure that knowledge of the product, disease, regulatory requirements, and idiosyncrasies of regulatory authorities are incorporated in regulatory submissions.

Product Development
Assist product development teams. Develop a clinical and regulatory component for each product development plan. Lead and participate in development of processes to meet corporate timelines. Drive strategic discussions with Product Development and Marketing groups, incorporating clinical and regulatory knowledge of the elements needed to obtain labeling targets.

Develop Clinical and Regulatory Organization
Build a clinical and regulatory organizational infrastructure to support key products at each stage in the development cycle. Assure that regulatory requirements are adequately communicated and resourced across functions. Apply lessons learned to future projects, educate the rest of the organization, and provide training to relevant staff.

Experience and Educational Background
Requires five to eight years of experience in the pharmaceutical or medical device industry. Some experience in Regulatory Affairs and relevant work experience in clinical and/or pre-clinical activities. Experienced in global regulatory authority interactions including package insert negotiations. Experience in protocol development, study implementation, clinical site management, and data collection and analysis.

Knowledge of FDA regulatory requirements, including GCP, is required. Knowledge of international regulatory guidelines desirable. Good presentation and communication skills, both written and verbal. Strong management, organizational and analytical skills. Ability to coordinate & influence across functional boundaries and resolve conflicts.

Ph.D., MD preferred, Masters degree or equivalent combination of education and experience in biological sciences or related field required.

Good publishing skills desirable such as knowledge of Documentum, CoreDossier, Europe SmPC, basic Word, Adobe Acrobat and general computer skills.

If you are interested in joining our team, please contact:
Carroll Cummings.

Note: E-mail submissions over the Internet may not be secure. Please consider this fact before e-mailing any personal or confidential information.

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