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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
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.
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.
Copyright
© 2008 Sensors for Medicine and Science, Inc.®
All rights reserved. Date of last update: 4/8/08.
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